REF/2014/08/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Sat, 12 May :19:03 GMT) CTRI Number Last Modified On 13/12/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/11/ [Registered on: 14/11/2014] - Trial Registered Prospectively No Interventional Biological Randomized, Parallel Group, Active Controlled Trial To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan(Rituximab)in patients with advanced Follicular Lymphoma, a type of cancer. A Phase 1/3, Randomised, Parallel-Group, Active-Controlled, Double-Blind Study to Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan, Each Administered in Combination With Cyclophosphamide, Vincristine, and Prednisone (CVP) in Patients With Advanced Follicular Lymphoma Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) EudraCT CT-P10 3.3Version1.1(incl country spec amend1-15jan2014) NCTO Designation Affiliation Protocol Number ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Arun Sundriyal Phone Fax Designation Affiliation Director - Clinical Management PPD Pharmaceutical Development India Pvt. Ltd PPD Pharmaceutical Development India Pvt. Ltd, Vatika City Point 11th floor, Sector 25, Mehrauli Gurgaon Road, Gurgaon Gurgaon HARYANA India Arun.Sundriyal@ppdi.com Details Contact Person (Public Query) Arun Sundriyal Director - Clinical Management PPD Pharmaceutical Development India Pvt. Ltd PPD Pharmaceutical Development India Pvt. Ltd, Vatika City Point 11th floor, Sector 25, Mehrauli Gurgaon Road, Gurgaon page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Gurgaon HARYANA India Phone Fax Source of Monetary or Material Support > CELLTRION Inc 13-6, Songdo-dong, Yeonsu-gu, Incheon, South Korea Type of Sponsor Primary Sponsor Details CELLTRION Inc 13-6, Songdo-dong, Yeonsu-gu, Incheon, South Korea Pharmaceutical industry-global PPD Pharmaceutical Development India Pvt Ltd List of Countries Belarus Brazil Bulgaria Chile Georgia Greece India Italy Mexico Netherlands Philippines Poland Portugal Republic of Korea Romania Russian Federation Serbia South Africa Spain Turkey Ukraine of Principal Investigator Dr Prabrajya Narayana Mohopatra Dr Bhandari Trilok Pratap Singh 01-Dynasty B-Wing (Kanakia Spaces), Andheri-Kurla Road, Andheri East, Mumbai , India of Site Site Phone/Fax/ Apollo Gleneagles Hospitals,Kolkata Apollo Hospitals Department of Medical Oncology,58-Canal Circular Road, Kolkata Kolkata WEST BENGAL Department of Oncology,Apollo Health City, Jubilee Hills ediffmail.com page 2 / 6

3 Details of Ethics Committee Dr Madras Ananthanarayanan Raja Dr Lalit Mohan Sharma Dr Prakash Nanasaheb Pandit Dr Muzammil Shahbuddin Shaikh Dr Kannan Subramanian Dr Rajesh Walvekar Apollo Speciality Hospital Bhagwan Mahaveer Cancer Hospital and Research Centre Curie Manavata Cancer Centre P D Hinduja National Hospital & Medical Research Centre Sahyadri Speciality Hospital Shatabdi Super Speciality Hospital Hyderabad ANDHRA PRADESH Dept of Oncology,320, Padma Complex, Mount Road, Teynampet Chennai TAMIL NADU Clinical Trial & Research Department,Jawahar Lal Nehru Marg Jaipur RAJASTHAN Opp.Mahamarg Bus Stand, Mumbai Naka Nashik Veer Savarkar Marg, Mahim Mumbai Department of Hematology and BMT Unit, 30 C, Erandawane, Karve Road Pune Opp. Mahamarg Bus Stand, Mumbai-Naka Nashik il.com drmaraja@hotmail.com drlalit2003@yahoo.com drpandit@mcrinasik.co m drmuzammils@yahoo.c om dockannan@gmail.com rajeshwalvekar@gmail. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee- Apollo Hospitals(Dr. TPS Bhandari) Ethics Committee-Apollo Hospitals, Apollo Hospitals(M A Raja) Institutional Ethics Comittee- P.D. Hinduja National Hospital & Medical Research Centre(Dr. Muzammil Shahbuddin Shaikh ) Institutional Ethics Committee -Bhagwan Mahaveer Cancer Hospitaland Research centre (Dr.Lalit MohanSharma) Approved 02/12/2014 No Submittted/Under Review Submittted/Under Review No Date Specified No Date Specified No No Approved 07/05/2014 No Institutional Ethics Approved 20/10/2014 No page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Committee-Apollo Gleneagles Hospitals,Kolkata(Dr. Prabrajya Narayana Mohopatra) Manavata Clinical Research InstituteEthics Committee(Dr. PrakashNanasaheb Pandit) Sahyadri Hospitals Ltd. Ethics Committee (Dr. Kannan Subramanian) Shatabdi Hospital Ethics Committee(Dr. Rajesh Walvekar) Status Approved 17/11/2014 No Approved 16/07/2014 No Approved 10/11/2014 No Date Approved/Obtained 10/11/2014 Health Type Patients Condition Advanced Follicular Lymphoma Type Details Intervention Comparator Agent Age From Age To Gender Details Biological: CT-P10 Other : rituximab Biological: rituximab Other : Rituxan Year(s) Year(s) Both Inclusion Criteria: Inclusion Criteria Experimental: CT-P10 will be administrated upto maximum of 8 cycles during the Core Study Period with CVP(cyclophosphamide, vincristine, prednisone) every 3 weeks. CT-P10 or Rituxan (375 mg/m2 IV) will be administered alone as maintenance in patients who have a response during the Core Study Period. Active Comparator: Rituximab(Rituxan) will be administrated upto maximum of 8 cycles during the Core Study Period with CVP(cyclophosphamide, vincristine, prednisone) every 3 weeks. CT-P10 or Rituxan (375 mg/m2 IV) will be administered alone as maintenance in patients who have a response during the Core Study Period. 1.Patient is male or female older than 18 years. 2.Patient has histologically confirmed FL according to the World Health Organization 2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review. 3.Patient has at least 1 measurable tumour mass that has not page 4 / 6

5 previously been irradiated, and the mass must be:?greater than 1.5 cm in the longest dimension or?between 1.1 and 1.5 cm in the longest dimension and greater than 1.0 cm in the shortest axis 4.Patient has confirmed CD20+ lymphoma, as assessed by local laboratory review. (Tissue obtained within 6 months before Day 1 of Cycle 1 will be reviewed by a central independent reviewer to detect pathological type.) 5.Patient has Ann Arbor stage III or IV disease. Exclusion Criteria Details Exclusion Criteria 1.Patient has received rituximab (or a rituximab biosimilar), cyclophosphamide, or vincristine. 2.Patient has allergies or hypersensitivity to murine, chimeric, human or humanised proteins, cyclophosphamide, vincristine, or prednisone. 3.Patient has evidence of histological transformation to high-grade or diffuse large B-cell lymphoma. 4.Patient has known central nervous system involvement. 5.Patient has received previous treatment for NHL: Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified randomization Centralized Participant, Investigator and Outcome Assessor Blinded?Previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or surgery (except previous biopsy)?all doses of corticoid therapy for treatment of NHL?Corticoid therapy during the previous 4 weeks from Day 1 of Cycle 1 with prednisone 20 mg per day for the treatment for any purpose Primary Outcome Outcome Timepoints Pharmacokinetics AUCtau: Area under the serum concentration-time curve at steady state CmaxSS: Maximum serum concentration at steady state week 12 Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Efficacy Overall Response rate - CR plus CRU plus PR CR: complete response CRu: unconfirmed complete response PR: partial response Total Sample Size=250 Sample Size from India=60 29/01/ /07/2014 Years=5 Months=6 Days=10 Closed to Recruitment of Participants Week 24 page 5 / 6

6 Powered by TCPDF ( REF/2014/08/ Recruitment Status of Trial (India) Publication Details Brief Summary Other (Terminated) NA This study is a Phase 1/3 prospective, randomised, parallel-group, active controlled, double blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate equivalence in pharmacokinetics (Part 1), as well as noninferiority in efficacy (Part 2), of CT-P10 to Rituxan when coadministered with CVP and to assess efficacy and safety in patients with advanced (stage III-IV) FL. Part 1 and Part 2 of the study will run in parallel. page 6 / 6