PDF of Trial CTRI Website URL -

Size: px
Start display at page:

Download "PDF of Trial CTRI Website URL -"

Transcription

1 Clinical Trial Details (PDF Generation Date :- Fri, 14 Dec :34:23 GMT) CTRI Number Last Modified On 07/02/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/01/ [Registered on: 06/01/2012] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Active Controlled Trial A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung (PROFILE 1014) Phase 3, Randomized, Open-Label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-Squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact A CT/97/11-DCG(I) dated 19-Dec-11, Protocol ver 2, 20 Dec 10 NCT Designation Affiliation Protocol Number DCGI ClinicalTrials.gov Details of Principal Investigator Swapnali Raut Director-Compliance Oversight Representing Pfizer Limited Phone Fax Designation Affiliation Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West,,, , C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Swapnali.raut@pfizer.com Details Contact Person (Scientific Query) Swapnali Raut Director-Compliance Oversight Representing Pfizer Limited Phone Fax Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West,,, , C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Swapnali.raut@pfizer.com Details Contact Person (Public Query) page 1 / 6

2 Person (Public Query) Swapnali Raut Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Designation Affiliation Director-Compliance Oversight Representing Pfizer Limited Phone Fax Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West,,, , C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Swapnali.raut@pfizer.com Source of Monetary or Material Support > Pfizer Limited, Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, , Primary Sponsor Details Pfizer Limited Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, , Type of Sponsor Nil List of Countries Australia Austria Belgium Brazil Canada Chile China Denmark Finland France Germany Hong Kong Ireland Italy Japan Luxembourg Mexico Netherlands Norway Peru Portugal Republic of Korea Russian Federation Singapore Pharmaceutical industry-global Nil page 2 / 6

3 Sites of Study Details of Ethics Committee South Africa Spain Switzerland Taiwan Turkey Ukraine United Kingdom United States of America of Principal Investigator Dr Ganesha D Vashishta Dr Kumar Prabhash Dr Sandip Abhay Shah of Site Site Phone/Fax/ Rajalakshmi Multispeciality Hospital Tata Memorial Centre, Tata Memorial Hospital The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital) Department is Not applicable. Rajalakshmi Multispeciality Hospital , V-R Layout 1 Phase - J.P. Nagar Bangalore, Karnataka INDIA Bangalore KARNATAKA Tata Memorial Centre, Tata Memorial Hospital, Dr. Ernest Borges Marg, Parel , Maharashtra, ganesha1705@gmail.c om kprabhash1@gmail.co m Department of Medical and Pediatric Oncology The Gujarat Cancer & sandip60@yahoo.com Research Institute (M.P Shah Cancer Hospital),Civil Hospital Campus, Asarwa, Ahmedabad,, Gujarat INDIA Ahmadabad GUJARAT of Committee Approval Status Date of Approval Is Independent Ethics Committee? Gujarat Cancer Society (GCS) & Gujarat Cancer and Research Institute (GCRI) Ethics Committee, The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital),Civil Hospital Campus, Ahmedabad for Dr. Sandip Abhay Shah Approved 07/09/2011 No Rajalakshmi Ethics Committee, Rajalakshmi Multispeciality, Bangalore for Dr. Ganesha D. Vashishta Approved 12/10/2011 No page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Tata Memorial Centre Institutional Review Board, Tata Memorial Hospital, for Dr. Kumar Prabhash Status Submittted/Under Review No Date Specified Date Approved/Obtained 19/12/2011 Health Type Patients Condition No Non Squamous Lung Cancer Type Details Intervention Comparator Agent Age From Age To Gender Details Experimental Intervention:: Crizotinib Active Comparator Intervention: pemetrexed and cisplatin or pemetrexed and carboplatin Year(s) Year(s) Both Inclusion Criteria crizotinib 250mg orally continuous twice daily dosing as long as the subject is in the study he will continue receiving the same. Unless any of these criteria is met. - Disease Progression - Withdrawal of consent - Death pemetrexed 500mg/m2 IV day 1 plus cisplatin 75mg/m2 IV day 1 every 21 days OR pemetrexed 500mg/m2 IV day 1 plus carboplatin AUC 5 or 6 day 1 every 21 days investigators choice for a maximum of 6 cycles 1. Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung 2. Positive for translocation or inversion events involving the ALK gene locus 3. No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids 4. Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures. Exclusion Criteria Details Exclusion Criteria 1. Current treatment on another therapeutic clinical trial. 2. Prior therapy directly targeting ALK. 3. Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. Appropriate treatment with anticoagulants is permitted. 4. Ongoing cardiac dysrhythmias of NCI CTCAE Grade greater than equal to 2, uncontrolled atrial fibrillation of any grade, or QTc interval greater than 470 msec. 5. Pregnancy or breastfeeding. 6. Use of drugs or foods that are known potent CYP3A4 page 4 / 6

5 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices. 7. Known HIV infection 8. Known interstitial lung disease or interstitial fibrosis 9. Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Open Label Primary Outcome Outcome Timepoints 1. Progression Free Survival [PFS] based on Response Evaluation Criterion in Solid Tumors [RECIST] version 1.1 (documented by independent radiology laboratory) Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 1. Objective Response Rate [ORR ] documented by independent radiology laboratory, and Duration of Response [DR] 2. Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) and any laboratory abnormalities 3. Plasma concentrations of crizotinib (including its active moieties, if appropriate) 4. Proportion of patients with each of the ALK fusion variants of the EML4-ALK fusion 5. Patient reported outcome measures of pain, dyspnea, or cough, disease/treatment-related symptoms, and general health status and Health Care Resource Utilization [HCRU] 6. Overall Survival [OS] at 6 months 12 months and overall Total Sample Size=334 Sample Size from =20 28/02/ /01/2011 Years=3 Months=0 Days=0 Completed Completed None page 5 / 6

6 Powered by TCPDF ( PDF of Trial This is a Phase 3, Randomized, Open-Label Study of the Efficacy and Safety of Crizotinib Versus Pemetrexed/Cisplatin or Pemetrexed/Carboplatin in previously untreated patients with Non-Squamous Carcinoma of the Lung harboring a translocation or inversion event involving the Anaplastic Lymphoma Kinase (ALK) gene locus A total of 334 patients will be randomized in a 1:1 ratio to receive crizotinib (Arm A) or chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin; Arm B). The choice of the platin chemotherapy will be made by the investigator. The randomization will be stratified by ECOG performance status (0-1 vs 2), race (Asian versus Non-Asian) and presence of brain metastases (presence or absence). Each treatment cycle is defined as 3 weeks. page 6 / 6

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Tue, 17 Jul 2018 00:15:16 GMT) CTRI Number Last Modified On 01/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sat, 21 Jul 2018 20:30:11 GMT) CTRI Number Last Modified On 11/04/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Tue, 17 Jul 2018 00:15:15 GMT) CTRI Number CTRI/2010/091/001049 [Registered on: 28/06/2010] - Last Modified On 01/02/2013 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Mon, 03 Sep 2018 18:46:09 GMT) CTRI Number Last Modified On 18/07/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 07 Oct 2018 14:20:17 GMT) CTRI Number Last Modified On 13/02/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 17 Apr 2019 04:44:33 GMT) CTRI Number Last Modified On 28/01/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 16 Sep 2018 18:58:45 GMT) CTRI Number Last Modified On 05/01/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Mon, 18 Mar 2019 01:33:59 GMT) CTRI Number CTRI/2009/091/000386 [Registered on: 24/09/2009] - Last Modified On 26/05/2016 Post Graduate Thesis Type of Trial

More information

Primary Endpoint The primary endpoint is overall survival, measured as the time in weeks from randomization to date of death due to any cause.

Primary Endpoint The primary endpoint is overall survival, measured as the time in weeks from randomization to date of death due to any cause. CASE STUDY Randomized, Double-Blind, Phase III Trial of NES-822 plus AMO-1002 vs. AMO-1002 alone as first-line therapy in patients with advanced pancreatic cancer This is a multicenter, randomized Phase

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 09 Nov 2018 00:53:13 GMT) CTRI Number Last Modified On 30/07/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 28 Nov 2018 03:04:58 GMT) CTRI Number CTRI/2009/091/000771 [Registered on: 28/10/2009] - Last Modified On 08/09/2014 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 28 Sep 2018 17:28:30 GMT) CTRI Number Last Modified On 25/10/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Thu, 22 Nov 2018 04:49:28 GMT) CTRI Number Last Modified On 25/04/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 08 Mar 2019 05:39:17 GMT) CTRI Number Last Modified On 21/11/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

REF/2012/08/ CTRI Website URL -

REF/2012/08/ CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 11 May 2018 23:49:14 GMT) CTRI Number Last Modified On 03/05/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 08 Mar 2019 04:26:40 GMT) CTRI Number Last Modified On 14/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 15 Jun 2018 08:45:14 GMT) CTRI Number CTRI/2010/091/000528 [Registered on: 12/07/2010] - Last Modified On 07/10/2014 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 19 Apr 2019 13:49:20 GMT) CTRI Number CTRI/2009/091/000126 [Registered on: 15/04/2009] - Last Modified On 03/09/2014 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sat, 01 Dec 2018 00:07:49 GMT) CTRI Number CTRI/2010/091/000387 [Registered on: 20/05/2010] - Last Modified On 15/03/2013 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 10 Oct 2018 02:19:24 GMT) CTRI Number Last Modified On 06/11/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sat, 09 Mar 2019 11:07:43 GMT) CTRI Number Last Modified On 08/08/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Thu, 18 Oct 2018 14:39:26 GMT) CTRI Number Last Modified On 06/04/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 07 Oct 2018 22:54:26 GMT) CTRI Number Last Modified On 11/05/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

REF/2013/09/ CTRI Website URL -

REF/2013/09/ CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 06 Dec 2017 05:29:00 GMT) CTRI Number Last Modified On 21/10/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Thu, 17 Jan 2019 04:33:43 GMT) CTRI Number Last Modified On 26/06/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 19 Dec 2018 02:45:15 GMT) CTRI Number Last Modified On 25/12/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 02 Nov 2018 11:52:50 GMT) CTRI Number Last Modified On 24/11/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

REFCTRI/2009/ CTRI Website URL -

REFCTRI/2009/ CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 22 Apr 2018 08:20:10 GMT) CTRI Number CTRI/2009/091/001024 [Registered on: 19/03/2010] - Last Modified On 05/11/2014 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 09 Nov 2018 18:49:36 GMT) CTRI Number CTRI/2010/091/001300 [Registered on: 05/10/2010] - Last Modified On 12/03/2013 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sat, 17 Nov 2018 21:22:46 GMT) CTRI Number Last Modified On 29/08/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Tue, 11 Dec 2018 13:01:44 GMT) CTRI Number Last Modified On 09/05/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

REF/2012/01/ CTRI Website URL -

REF/2012/01/ CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sat, 05 May 2018 05:20:32 GMT) CTRI Number Last Modified On 06/04/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 23 Nov 2018 06:48:34 GMT) CTRI Number Last Modified On 18/02/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 07 Dec 2018 19:05:34 GMT) CTRI Number CTRI/2009/091/000669 [Registered on: 01/12/2009] - Last Modified On Post Graduate Thesis Type of Trial Type of

More information

REF/2015/03/ CTRI Website URL -

REF/2015/03/ CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 02 May 2018 19:39:07 GMT) CTRI Number Last Modified On 30/01/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

REF/2014/03/ CTRI Website URL -

REF/2014/03/ CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 28 Feb 2018 22:13:58 GMT) CTRI Number Last Modified On 13/02/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 20 Jan 2019 21:39:27 GMT) CTRI Number CTRI/2009/091/000777 [Registered on: 11/01/2010] - Last Modified On Post Graduate Thesis Type of Trial Type of

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Tue, 09 Apr 2019 10:09:21 GMT) CTRI Number Last Modified On 18/09/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 02 Sep 2018 23:38:24 GMT) CTRI Number Last Modified On 05/02/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 23 v 2018 09:27:36 GMT) CTRI Number Last Modified On 30/06/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific

More information

REF/2014/04/ CTRI Website URL -

REF/2014/04/ CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 02 May 2018 19:38:55 GMT) CTRI Number Last Modified On 13/12/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 07 Apr 2019 21:50:45 GMT) CTRI Number Last Modified On 11/03/2019 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Tue, 08 Jan 2019 13:37:20 GMT) CTRI Number Last Modified On 23/11/2011 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 21 Nov 2018 00:19:07 GMT) CTRI Number CTRI/2010/091/000067 [Registered on: 10/02/2010] - Last Modified On 12/03/2013 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 12 Dec 2018 14:35:45 GMT) CTRI Number Last Modified On 15/01/2013 Post Graduate Thesis Type of Trial Type of Study Study Design CTRI/2011/12/002273 [Registered

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 30 Dec 2018 00:34:16 GMT) CTRI Number CTRI/2009/091/000652 [Registered on: 27/10/2009] - Last Modified On 11/03/2014 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sat, 23 Feb 2019 02:27:19 GMT) CTRI Number CTRI/2009/091/000044 [Registered on: 17/02/2009] - Last Modified On Post Graduate Thesis Type of Trial Type of

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Tue, 19 Mar 2019 18:08:08 GMT) CTRI Number CTRI/2009/091/000355 [Registered on: 22/01/2010] - Last Modified On Post Graduate Thesis Type of Trial Type of

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 27 Mar 2019 20:50:17 GMT) CTRI Number CTRI/2009/091/001039 [Registered on: 15/10/2010] - Last Modified On 11/06/2015 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Tue, 17 Jul 2018 08:11:24 GMT) CTRI Number Last Modified On 10/06/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 10 Mar 2019 08:06:47 GMT) CTRI Number Last Modified On 13/11/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 08 Mar 2019 23:58:25 GMT) CTRI Number CTRI/2009/091/000399 [Registered on: 17/11/2009] - Last Modified On 15/01/2015 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 22 Feb 2019 22:24:32 GMT) CTRI Number Last Modified On 06/11/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Tue, 16 Apr 2019 03:04:45 GMT) CTRI Number Last Modified On 29/11/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 07 Apr 2019 02:55:48 GMT) CTRI Number CTRI/2009/091/000750 [Registered on: 09/10/2009] - Last Modified On 14/08/2014 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 01 Feb 2019 06:46:32 GMT) CTRI Number Last Modified On 02/06/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 14 Apr 2019 16:03:43 GMT) CTRI Number Last Modified On 30/10/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 05 Oct 2018 20:16:50 GMT) CTRI Number Last Modified On 07/08/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 08 Mar 2019 17:21:25 GMT) CTRI Number CTRI/2009/091/000251 [Registered on: 24/06/2009] - Last Modified On 29/12/2017 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Thu, 26 Jul 2018 10:07:49 GMT) CTRI Number CTRI/2008/091/000256 [Registered on: 23/02/2010] - Last Modified On 20/11/2015 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 17 Mar 2019 01:47:34 GMT) CTRI Number Last Modified On 05/06/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 17 Apr 2019 02:24:18 GMT) CTRI Number Last Modified On 16/08/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 26 Oct 2018 15:38:49 GMT) CTRI Number Last Modified On 12/12/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sat, 03 Nov 2018 05:20:48 GMT) CTRI Number Last Modified On 12/12/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 12 Sep 2018 12:18:27 GMT) CTRI Number Last Modified On 04/07/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 06 Mar 2019 11:42:44 GMT) CTRI Number CTRI/2009/091/000382 [Registered on: 09/07/2009] - Last Modified On Post Graduate Thesis Type of Trial Type of

More information

FOURIER STUDY GREYLOCK PRESS: CTS PRODUCT SAMPLE - FOURIER YES. Did the study achieve its main objective?

FOURIER STUDY GREYLOCK PRESS: CTS PRODUCT SAMPLE - FOURIER YES. Did the study achieve its main objective? FOURIER STUDY Did the study achieve its main objective? 2 15% 1 5% 9.8% YES FOURIER compared Repatha with placebo in patients who were taking a statin and had hardening or narrowing of the arteries and

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 25 Jul 2018 16:16:54 GMT) CTRI Number Last Modified On 16/05/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 31 Mar 2019 14:01:04 GMT) CTRI Number Last Modified On 11/07/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Mon, 14 Jan 2019 04:12:22 GMT) CTRI Number Last Modified On 25/08/2011 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

Kenneth W. Mahaffey, MD and Keith AA Fox, MB ChB

Kenneth W. Mahaffey, MD and Keith AA Fox, MB ChB Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation Kenneth W. Mahaffey, MD and Keith AA Fox, MB ChB on behalf

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 09 Nov 2018 19:32:51 GMT) CTRI Number Last Modified On 23/08/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 17 Mar 2019 03:23:33 GMT) CTRI Number Last Modified On 03/02/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Wed, 17 Apr 2019 02:24:33 GMT) CTRI Number Last Modified On 23/06/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 28 Dec 2018 03:48:30 GMT) CTRI Number Last Modified On 28/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Tue, 16 Apr 2019 09:11:00 GMT) CTRI Number Last Modified On 04/10/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 12 Apr 2019 07:28:50 GMT) CTRI Number Last Modified On 18/05/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sat, 24 Nov 2018 15:12:21 GMT) CTRI Number Last Modified On 22/10/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sat, 06 Oct 2018 18:04:10 GMT) CTRI Number Last Modified On 02/06/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

ALK Inhibition: From Biology to Approved Therapy for Advanced Non-Small Cell Lung Cancer

ALK Inhibition: From Biology to Approved Therapy for Advanced Non-Small Cell Lung Cancer ALK Inhibition: From Biology to Approved Therapy for Advanced Non-Small Cell Lung Cancer Dr. Ben Solomon Medical Oncologist, Thoracic Oncology Peter MacCallum Cancer Centre Melbourne, Australia Dr. D.

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sat, 17 Nov 2018 14:20:06 GMT) CTRI Number Last Modified On 10/05/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

REF/2014/01/ CTRI Website URL -

REF/2014/01/ CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sat, 05 May 2018 05:20:40 GMT) CTRI Number Last Modified On 08/03/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Tue, 15 Jan 2019 07:37:18 GMT) CTRI Number Last Modified On 26/03/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting A service of the U.S. National Institutes of Health Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting Trial record 1 of 1 for: Keynote 355 Previous Study Return to List

More information

Conducting Successful Oncology Clinical Trials in Asia Pacific: PharmaNet experience using Case Studies

Conducting Successful Oncology Clinical Trials in Asia Pacific: PharmaNet experience using Case Studies Conducting Successful Oncology Clinical Trials in Asia Pacific: PharmaNet experience using Case Studies Emily Tan Executive Director Asia Pacific PharmaNet Conducting Successful Oncology Clinical Trials

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Thu, 18 Oct 2018 01:14:31 GMT) CTRI Number Last Modified On 06/06/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

Plattenepithelkarzinom des Ösophagus, 1 st -line

Plattenepithelkarzinom des Ösophagus, 1 st -line Plattenepithelkarzinom des Ösophagus, 1 st -line AIO-STO-0309 An open-label, randomized phase III trial of cisplatin and 5-fluorouracil with or without panitumumab for patients with nonresectable, advanced

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Mon, 21 Jan 2019 19:40:34 GMT) CTRI Number CTRI/2009/091/000051 [Registered on: 08/04/2009] - Last Modified On Post Graduate Thesis Type of Trial Type of

More information

REFCTRI/2010/ CTRI Website URL -

REFCTRI/2010/ CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Mon, 23 Apr 2018 20:30:46 GMT) CTRI Number CTRI/2010/091/000460 [Registered on: 15/10/2010] - Last Modified On 17/04/2012 Post Graduate Thesis Type of Trial

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 08 Mar 2019 15:58:14 GMT) CTRI Number Last Modified On 26/12/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Tue, 09 Oct 2018 14:20:31 GMT) CTRI Number Last Modified On 23/07/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

REF/2011/11/ CTRI Website URL -

REF/2011/11/ CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Fri, 24 Nov 2017 03:47:32 GMT) CTRI Number Last Modified On 15/01/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Thu, 15 Nov 2018 17:31:39 GMT) CTRI Number Last Modified On 01/10/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information