Stage IV Metastatic Melanoma MedDRA version: 9.1 Level: LLT Classification code 10027480 Term: Metastatic malignant melanoma
Conditions
Interventions
Product Code: STA-4783
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 488832-69-5
Current Sponsor code: STA-4783
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Synta Pharmaceuticals Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject is eligible for the study if all of the following criteria are met: -must be at least 18 years of age -if female or childbearing potential or male, willing to use two forms of effective contraception during study treatment -must have histologically confirmed melanoma of cutaneous origin -must have Stage IV melanoma -must have Eastern Coorporative Oncology Group (ECOG) performance status of or = 8g/dL (SI units: > or = 80 g/L) *Absolute neutrophil count > or = 1500/mm3 (SI units: > or = 1500 GI/L) *Platelet count > or = to 100,000/mm3 (SI units: > or = 100,000 GI/L) *Creatinine 1.5 mg/dL, subject is eligible if creatinine clearance > or = to 60 mL/min using the Cockgroft-Gault equation) *Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject is excluded from the study if any of the folllowing criteria are met: -female subjects who are pregnant or nursing -presence or history (> or = 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ -presence of an active infection requiring intravenous antibiotics, a serious local infection (eg, cellulitis, abscess) or systemic infection (eg, pneumonia, septicemia) which required systemic antibiotic treatment within 2 weeks prior to the first dose of study medication -presence of a potentially drug-induced peripheral neuropathy that is assessed as Grade 2 or greater based on the NCI CTCAE criteria version 3.0 -history of or clinical symptoms of central nervous system metastases -presence of any brain metastases (as determined by contrast computed tomography (CT) or magnetic resonance imaging (MRI) scan performed during screening -presence of clinically significant cardiac arrhythmias -known to be HIV positive -needs chronic immunosuppressive therapy (eg, cyclophosphamide following transplantation) -has had surgery within 2 weeks (1 week for minor surgery, eg, procedures requiring only local anesthetics) prior to the first dose of study medication -use of "complementary" anti-cancer therapy (prescription or over the counter, including herbal remedies or high-dose antioxidants) within 2 weeks prior to the first dose of study medication and for the duration of the study -presence of a serious concurrent illness or other condition (eg, psychological, family, sociological, or geographical circumstances) that does not permit adequate follow-up and compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of STA-4783 in combination with paclitaxel in comparison with paclitaxel alone, based on progression-free survival (PFS);Secondary Objective: To assess overall survival (OS) To assess the objective response rate (ORR) To assess the clinical benefit rate (proportion of subjects who have CR or PR, or SD for at least 24 weeks) To assess the duration of objective response To further characterize the safety of STA-4783 in combination with paclitaxel in comparison with paclitaxel alone To further characterize the pharmacokinetics of STA-4783 in combination with paclitaxel;Primary end point(s): The primary efficacy endpoint is Progression Free Survival (PFS) | — |
Countries
Belgium, Czech Republic, France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed