advanced-stage soft tissue sarcoma treated with cisplatin after failure of anthracycline and ifosfamide chemotherapies.
Conditions
Interventions
Product Code: AVE8062
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 253426-24-3
Current Sponsor code: AVE8062 hydrochloride
Concentration unit: mg/ml milligram(s)/millilitre
C
Sponsors
sanofi-aventis recherche et développement
Eligibility
Sex/Gender
All
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patient consent form not obtained, signed and dated - Less than 18 years old - ECOG Performance Status (PS) > 2 - Life expectancy shorter than 12 weeks. - Patients with well controlled primary disease and who are candidates to total surgical resection of metastasis (1 or more lesions) before study randomization. - Brain metastases and carcinomatous leptomeningitis. - More than two previous chemotherapy regimens for advanced disease. - Prior intensive chemotherapy with autologous stem cell rescue - Prior treatment with Tyrosine Kinase inhibitors (TKI) (specific or multitargeted agents) - 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. - Only lesions 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. - Pregnant or breast-feeding women. Positive serum or urine pregnancy test for women prior to randomization - 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. - Washout period of less than 3 weeks from prior 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 3.5 g/24h). - Patient with LVEF value lower than 50 % for institution inferior normal limit, evaluated by echocardiography, or by radionuclide assessment. - Ischemic event within 1 year prior to study entry including but not limited to: stroke, angor, whatever the anatomical site, diagnosis of at least one symptomatic coronary insufficiency - Uncontrolled hypertension - Uncontrolled a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the progression-free survival (PFS) in the 2 treatment arms;Secondary Objective: - To compare the overall survival (OS) in the 2 treatment arms - To compare the objective response rate (RR) in the 2 treatment arms - To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy) - To assess the pharmacokinetics (PK) of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers. -To assess genotypes of drug metabolizing enzymes in all enrolled patients in blood sampling collected before the first study drug infusion.;Primary end point(s): The primary efficacy endpoint is progression-free survival (PFS) defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever comes first. An independent review committee (IRC) blinded to the randomization arm and to the patient characteristics, will assess objective radiological tumor progression. | — |
Countries
Belgium, France, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed