Health Condition 1: null- Advance-stage soft tissue sarcoma Health Condition 2: C499- Malignant neoplasm of connective and soft tissue, unspecified
Conditions
Interventions
Intervention1: AVE8062 (Ombrabulin): (25 mg/m²
) administered every 3 weeks - IV infusion
Control Intervention1: Cisplatin: (75 mg/m²) administered every 3 weeks - IV infusion
Control Intervention2: Placebo: Administered every 3 weeks (IV inf
Sponsors
SanofiSynthelabo India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) Timepoint: until event or study cut-off date (Tumor assessment every 6 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Safety Pharmacokinetic Analysis Timepoint: until event or study cut-off date | — |
Countries
Belgium, Brazil, France, Hungary, India, Italy, Spain, United Kingdom, United States of America
Contacts
Public ContactParesh
i3 Research
Outcome results
None listed