Clinical Trial Details (PDF Generation Date :- Fri, 14 Dec 2018 00:34:23 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/2012/01/002323 [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 A8081014 CT/97/11-DCG(I) dated 19-Dec-11, Protocol ver 2, 20 Dec 10 NCT01154140 Designation Affiliation Protocol Number DCGI ClinicalTrials.gov Details of Principal Investigator Swapnali Raut Director-Compliance Oversight Representing Pfizer Limited Phone 91-9821415224 Fax 91-22-26525993 Email Designation Affiliation Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West,,, 400 102, C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), 400098. 400102 Swapnali.raut@pfizer.com Details Contact Person (Scientific Query) Swapnali Raut Director-Compliance Oversight Representing Pfizer Limited Phone 91-9821415224 Fax 91-22-26525993 Email Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West,,, 400 102, C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), 400098. 400102 Swapnali.raut@pfizer.com Details Contact Person (Public Query) page 1 / 6
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 91-9821415224 Fax 91-22-26525993 Email Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West,,, 400 102, C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), 400098. 400102 Swapnali.raut@pfizer.com Source of Monetary or Material Support > Pfizer Limited, Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, 400 102, Primary Sponsor Details Pfizer Limited Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, 400 102, 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
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/Email 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 76-1-1, V-R Layout 1 Phase - J.P. Nagar Bangalore, Karnataka 560 078 INDIA Bangalore KARNATAKA Tata Memorial Centre, Tata Memorial Hospital, Dr. Ernest Borges Marg, Parel - 400012, Maharashtra, 91-080-25633847 91-080-25504356 ganesha1705@gmail.c om 91-9224182898 91-22-24171734 kprabhash1@gmail.co m Department of Medical 91-79-22688000 and Pediatric Oncology. 91-79-22685490 The Gujarat Cancer & sandip60@yahoo.com Research Institute (M.P Shah Cancer Hospital),Civil Hospital Campus, Asarwa, Ahmedabad,, Gujarat 380 016 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
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 18.00 Year(s) 65.00 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
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 28/02/2013 01/01/2011 Years=3 Months=0 Days=0 Completed Completed None page 5 / 6
Powered by TCPDF (www.tcpdf.org) 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