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1 Clinical Trial Details (PDF Generation Date :- Wed, 06 Mar :42:44 GMT) CTRI Number CTRI/2009/091/ [Registered on: 09/07/2009] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Randomized, Parallel Group, Multiple Arm Trial A Multicenter, Open-Label, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of NKTR-102 (PEG-Irinotecan) Versus Irinotecan in Patients with Second-Line, Irinotecan-Naïve, KRAS-Mutant, Metastatic Colorectal Cancer (mcrc). A Multicenter, Open-Label, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of NKTR-102 (PEG-Irinotecan) Versus Irinotecan in Patients with Second-Line, Irinotecan-Naïve, KRAS-Mutant, Metastatic Colorectal Cancer (mcrc). 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 Person (Public Query) 08-PIR-03 NCT Protocol Number ClinicalTrials.gov Details of Principal Investigator Name Dr Pramod Kabra, MD [overall Trial Coordinator in ] Designation Affiliation Phone Fax Name Designation Affiliation Phone Fax Pharmaceutical Research Associate,402, Business Square Andheri-Kurla Road,Andheri [E] KabraPramod@PRAIntl.com Details Contact Person (Scientific Query) Dr Pramod Kabra, MD [overall Trial Coordinator in ] Pharmaceutical Research Associate,402, Business Square Andheri-Kurla Road,Andheri [E] KabraPramod@PRAIntl.com Details Contact Person (Public Query) Name Dr Pramod Kabra, MD [overall Trial Coordinator ] Designation Affiliation Pharmaceutical Research Associate,402, Business Square Andheri-Kurla Road,Andheri [E] page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > Nektar Therapeutics Inc. 201 Industrial Road San Carlos, CA USA Name Type of Sponsor Name NIL List of Countries Name of Principal Investigator Dr.Keechilat Pavithran Dr. Chanchal Goswami Dr. Kalyan Kusum Mukherjee Dr.Rajnish Nagarkar Dr.Sandip Shah Dr. Ashish Bakshi Dr.Unmesh Takalkar Primary Sponsor Details Nektar Therapeutics Inc Name of Site Site Phone/Fax/ Amrita Institute of Medical Sciences B.P. Poddar Hospital and Medical Research Ltd. Chittaranjan National Cancer Institue Curie Manavata Cancer Centre Hemato-Oncology Clinic Ahmedabad Pvt.Ltd. Kaushalya Medical Foundation Trust Hospital Kodlikeri Memorial Hospital Dept. of Medical Oncology,Amrita Lane,Elamkkara Not Applicable N/A 71/1, Humayn Kabir Sarani,New Alipore, Block G Kolkata WEST BENGAL 37,S. P.Mukherjee Road,Kalighat Not Applicable N/A Opp.Mahamarg Bus Stop, Naka Nashik a.edu il.com in Vedanta,Near Samved Hospital,Commerce College Road,Navrangp ura Ahmadabad GUJARAT Ganeshwadi,Panchpak hadi,behind Nitin Company,Thane [W] ,Manjeet Nagar,Opp Akashwani,Jalna Road Aurangabad page 2 / 6

3 Details of Ethics Committee Dr.Nalini Kilara Dr. Mukta Srinivasulu Dr. Radheshyam Naik Dr. Shailesh Bondarde M.S. Ramaiah Memorial Hospitial Mehendi Nawaz Jung Institute of Oncology and Regional Cancer Centre Rajalakshmi Multispeciality Hospital BIHAR Dept. of Medical Oncology,New BEL Road Bangalore KARNATAKA Red Hills, Hyderabad ANDHRA PRADESH ,V.R.Layout,1st Phase, J.P.Nagar Bangalore KARNATAKA Shatabti opp Mahamarg Bus Superspeciality Hospital Stop, Naka Nashik m o.co.in com oo.com Name of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethical CommitteeB.P. Podar Hospital and Medical Research Ltd. Ethics Committee Ethics Committee MNJ Institute of Oncology & Regional Cancer Center Ethics Committee of the Heart Care Clinic, Insitutional Ethical Committee, Chittaranjan National Cancer Institute Institutional Ethics Committee Amrita Institute of Medical Sciences Kaushalya Medical Foundation and Trust Hospital M.S. Ramaiah Medical College and Teaching Hospital Ethical Review Board Manavata Clinical Research Institute Professional Ethics Committee Rajalakshmi Ethics Committee Shatabdi Hospital Ethics Committee Submittted/Under Review Not Available Submittted/Under Review Not Available Submittted/Under Review Not Available page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Status Approved/Obtained Health Type Date Condition Patients with Second-Line, Irinotecan-Naïve, KRAS-Mutant, Metastatic Colorectal Cancer (mcrc). Type Name Details Intervention NKTR-102 (PEG-irinotecan) 145 mg/m2 given IV every 21 days as a 90 minute infusion Comparator Agent Irinotecan 350 mg/m2 given IV every 21 days as a 90 min infusion (Patients age 65 or older or those with prior abdominal or pelvic irradiation randomized to Arm B will be given a lower dose of 300 mg/m2 of Irinotecan) Age From Age To Gender Details Inclusion Criteria Each patient must meet the following criteria to be enrolled in this study: 1. Provide signed and dated informed consent prior to study-specific screening procedures years old. 3. Patients must have histological confirmation of colorectal adenocarcinoma. Patients must have metastatic disease with at least 1 uni-dimensionally measurable lesion meeting RECIST version 1.1 guidelines. 4. KRAS mutation determined from tumor tissue (primary tumor or metastasis). 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or Patients must have received at least 1 but no more than 1 prior fluoropyrimidine-containing regimen in the metastatic setting and must be naïve to irinotecan. Patients may also have received a fluoropyrimidine in the adjuvant setting. 7. Standard prior radiation therapy for rectal cancer is allowed. Patients must have recovered from the toxic effects of radiation prior to study enrollment. Prior radiotherapy must be completed 28 days before study entry. Lesions that have been radiated in the advanced setting cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy. 8. Adequate organ and bone marrow function at the Screening Visit defined as: a. Absolute neutrophil count 1,500/mm3 without myeloid growth factor support for 21 days preceding the lab assessment b. White blood cell (WBC) count 3,000/mm3 without myeloid growth factor support for 21 days preceding the lab assessment c. Platelet count 100,000/mm3, without transfusion within 7 days preceding the lab assessment d. Hemoglobin 9 g/dl, without transfusion support e. Total bilirubin 2 mg/dl f. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 3 x upper limit of normal (ULN) ( 5 x ULN if the presence of liver metastasis is confirmed) g. Creatinine 1.5 times ULN or creatinine clearance 60 ml/min 9. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Cycle 1 Day Women of childbearing potential, or men whose female partners are of childbearing potential, must agree to use at least 2 forms of page 4 / 6

5 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Stratified randomization Centralized Open Label contraception, 1 of which includes a barrier method (male condom) by the male partner, during the treatment period. Appropriate contraception must be used for at least 8 months after the last dose of the study drug. 11. Patients must be able and willing to comply with the study visit schedule and study procedures. Exclusion Criteria Patients who meet any of the following criteria will not be permitted entry to the study: 1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1, and have not, as deemed by the Investigator, recovered to NCI-CTCAE Grade 0 or 1 toxicity (any NCI-CTCAE grade of alopecia is allowed) associated with previous treatment irrespective of the interval from the last treatment. 2. Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle 1 or minor surgery within 2 weeks of Day 1 of Cycle Administration of any of the following CYP3A4 inducer or inhibitor: phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, St. John's Wort, ketoconazole, neuromuscular agents or atazanavir sulfate within 2 weeks prior to the first day of study drug treatment. 4. Patients cannot have concomitant use of biologic agents including antibodies (e.g., bevacizumab, trastuzumab, etc.) as well as investigational agents. 5. Patients who have received any treatment with a camptothecin derivative (e.g., irinotecan, topotecan, SN-38 investigational agents, etc.). 6. Known or suspected central nervous system metastases. 7. Pregnant or lactating. 8. Other malignancy within the past 5 years except for any of the following: non-melanoma skin cancer, carcinoma in situ of the cervix, or any another malignancy with no evidence of recurrence for more than 5 years. Patients with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously. 9. Liver cirrhosis. 10. Interstitial pneumonitis. 11. Any other significant co-morbid conditions that, in the judgment of the Investigator, would impair study participation or cooperation. 12. Patients with a history of hypersensitivity or intolerance to other PEGylated drugs or to the excipients of irinotecan/camptosar. 13. Patients with inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), unresolved bowel issues (e.g., diverticulitis, ileitis, colitis, complete bowel obstruction etc.) or patients with chronic or acute gastrointestinal disorders with diarrhea as a major symptom. Primary Outcome Outcome Timepoints 1 To estimate the progression-free survival (PFS) with NKTR-102 versus irinotecan Secondary Outcome Outcome Timepoints 1 To estimate the overall survival (OS) with NKTR-102 versus irinotecan. To determine the objective response rate (ORR) and response duration with NKTR-102 versus irinotecan. To characterize the safety profile of NKTR-102. To evaluate the PK of NKTR-102 or irinotecan and their respective metabolites, in a subset of patients page 5 / 6

6 Powered by TCPDF ( Target Sample Size Phase of Trial Phase 2 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 Total Sample Size=0 Sample Size from = 01/07/2009 Years= Months=0 Days=0 Open to Recruitment This is Multicenter, Open-Label, Randomized, Phase 2 Study to evaluate whether NKTR-102, an investigational drug has an anti-tumor effect in patients with colorectal cancer. This study will also evaluate how the safety and anti-tumor activity of NKTR-102 compares with irinotecan, a cancer drug that is approved for use in treatment of patients with certain types of colorectal cancer. page 6 / 6