REFCTRI/2009/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Sun, 22 Apr :20:10 GMT) CTRI Number CTRI/2009/091/ [Registered on: 19/03/2010] - Last Modified On 05/11/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Placebo Controlled Trial A Study of AVE8062 in Advanced-Stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies A multinational, randomized, double-blind placebo controlled study of AVE8062 (25 mg/m²) administered every 3 weeks, in patients with advanced-stage soft tissue sarcoma treated with cisplatin (75 mg/m²) after failure of anthracycline and ifosfamide chemotherapies. 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) EFC10145 NCT Protocol Number ClinicalTrials.gov Details of Principal Investigator Dr Sanath Hegde Principal Investigator Phone Fax Consultant Medical Oncologist. FR. Muller Hospital Department of Radiation Oncology Kankanady drhegdesanath@gmail.com Details Contact Person (Scientific Query) Paresh CRA Ahmadabad GUJARAT Phone Fax paresh.patel@i3research.com Details Contact Person (Public Query) Paresh CRA Ahmadabad GUJARAT Phone page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Fax Source of Monetary or Material Support > Sanofi-Synthelabo () Limited 54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mumbai Primary Sponsor Details SanofiSynthelabo Limited 54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mumbai Type of Sponsor List of Countries Belgium Brazil France Hungary Italy Spain United Kingdom United States of America of Principal Investigator Dr. Srinivas Chakravarthy Dr Sanath Hegde Dr. Nalini Kilara Dr. Rohit Nayyar Pharmaceutical industry-global of Site Site Phone/Fax/ Apollo Hospitals FR. Muller Hospital Department of Radiation Oncology Gokula Metropolis Clinical Research Cente Apollo Hospital, Education & Research Foundation (Spectria Clinical Research), Apollo Health City Jubilee Hills,, Hyderabad ANDHRA PRADESH Kankanady, m com Department of Medical Oncology, MS Ramaiah Memorial Hospital, nalini_kilara@yahoo.co,new Bel Road m Basement hostel complex, Indraprastha Apollo Hospital,,Sarita Vihar New Delhi DELHI Aherf_delhi@apollohos pitals.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? CentralApolloHospitals Approved 03/01/2009 No GroupEC/Hyderabad/Dr SrinivasChakravarthy CentralEC/NewDelhi/Dr RohitNayyar FatherMullerMedicalCol legeinstitutinalec_man Approved 20/02/2009 No Approved 03/11/2008 No page 2 / 5

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria galore_drysanathhedg e M.S. Ramaiah Medical College & Teaching Hospital Ethical Review Board//DrNali nikilara Approved 19/07/2008 No Status Date Approved/Obtained 20/10/2008 Health Type Patients Condition Advance-stage soft tissue sarcoma Type Details Intervention AVE8062 (Ombrabulin) (25 mg/m²) administered every 3 weeks - IV infusion Comparator Agent Cisplatin (75 mg/m²) administered every 3 weeks - IV infusion Comparator Agent Placebo Administered every 3 weeks (IV infusion) Age From Age To Gender Year(s) Year(s) Both Inclusion Criteria Details Histologically proven STS at the first diagnosis Unresectable locoregional recurrent OR metastatic soft tissue sarcoma - Failure of a previous anthracycline-based regimen administered at recommended dose and of prior ifosfamide therapy - Disease progression within 1 month before study randomization Exclusion Criteria Details Exclusion Criteria "1Patient consent form not obtained, signed and dated. 2 Less than 18 years old. 3 ECOG Performance Status (PS) > 2. 4 Life expectancy shorter than 12 weeks. 5 Patients with well controlled primary disease and who are candidates to total surgical resection of metastasis (1 or more lesions) before study randomization. 6 Brain metastases and carcinomatous leptomeningitis. 7 More than two previous chemotherapy regimens for advanced disease. 8 Prior intensive chemotherapy with autologous stem cell rescue. 9 Prior treatment with Tyrosine Kinase inhibitors (TKI) (specific or multitargeted agents). 10 Only lesion/s previously irradiated (i.e. lesions not evaluable) if no other evaluable lesions are present. At study entry, in the case of one single metastatic target lesion, histological or cytological proof to metastasis should be obtained. 11 History of other cancer. Adequately treated basal cell or squamous cell skin cancers, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for > 5 years are allowed. 13 Pregnant or breast-feeding women. Positive serum or urine pregnancy test for women prior to randomization. 14 Patients with reproductive potential (M/F) who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 3 months after the completion of the study treatment. The definition of?effective method of contraception? will be based on the investigator's judgment. For patients enrolled in the United Kingdom, the following method of contraception are acceptable: Oral contraceptives accompanied by the use of a second method of contraception, (as it is not known how oral contraceptives page 3 / 5

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized interact with all the study medications) or Intra Uterine Device (IUD) or women who are surgically sterile or women who are post-menopausal or for other reasons have no chance of becoming pregnant. Female partners of male patient must follow the same contraceptive methods as mentioned above. 15 Washout period of less than 3 weeks prior to anti-tumor therapy (chemotherapy, targeted agents, and radiotherapy) or any investigational treatment, except for nitrosoureas, mitomycin C which may not be used up to 6 weeks prior to the randomization date, provided that patients do not have residual signs of any toxicity.? Complete initial work up earlier than 3 weeks prior to patient randomization.? Patient?s inability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.? Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, radiotherapy, targeted therapy, gene therapy, or patients planning to receive these treatments during the study.? Other severe illness or medical conditions such as and not exhaustive: 1. Active infection. 2. Superior Vena Cava Syndrome. 3. Severe chronic obstructive pulmonary disease (COPD) and/or extensive pulmonary fibrosis (arterial blood gases PAO2 < 60 or non invasive oximetry SaO2 < 90). 4. Pericardial effusion requiring intervention (drainage). 5. Severe proteinuria (Grade 3-4, > 3.5 g/24h).? Patient with LVEF value lower than 50 % or institution inferior normal limit, evaluated by echocardiography, or by radionuclide assessment.? Ischemic event within 1 year prior to study entry including but not exhaustive: stroke, angor, whatever the anatomical site, diagnosis of at least one symptomatic coronary insufficiency.? Uncontrolled hypertension.? Uncontrolled arrhythmia particularly severe conduction disorder such as second or third-degree atrio-ventricular block.? Thrombo-embolism requiring anticoagulants within the past 6 months..? Blood marrow: neutrophils < 1.5 x 109/L; platelets <100 x 109/L.? Kidney function: creatinine > 1.5 mg/dl. If creatinine 1.5 mg/dl, the calculated creatinine clearance should be 60 ml/min (Appendix B Cockroft-Gault Formula).? Liver function: Total bilirubin value > normal limit; ALT/AST/AP 2.5 times the upper normal limits of the institutional norms. An increase of AP ( grade 2) would be accepted only if this increase is related to the presence of bone metastases.? Known platinum compounds hypersensitivity.? Current peripheral neuropathy > grade 1 according to the NCI CTCAE classification, of any origin including significant residual symptoms due to the use of neurotoxic drugs (e.g. vinca- alkaloids, platinum or taxans). Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Progression-free survival (PFS) until event or study cut-off date (Tumor assessment every 6 weeks) Secondary Outcome Outcome Timepoints Efficacy Safety Pharmacokinetic Analysis until event or study cut-off date Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Total Sample Size=300 Sample Size from =50 04/03/2009 page 4 / 5

5 Powered by TCPDF ( REFCTRI/2009/ Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 09/06/2008 Years=3 Months=0 Days=0 Completed Completed Not yet available This is a multinational, prospective, double-blind placebo-controlled randomized parallel group trial in patients with unresectable locally advanced or metastatic soft tissue sarcome. A multinational, randomized, double-blind placebo controlled study of AVE8062 (25 mg/m²) administered every 3 weeks, in patients with advanced-stage soft tissue sarcoma treated with cisplatin (75 mg/m²) after failure of anthracycline and ifosfamide chemotherapies. This trial is conducted in 10 countries all over the world. The n target -25 patients n, status -2 patients randomized till date- Planned date of first enrolment - 11 Feb page 5 / 5