A Randomized, Double-blind, Phase 3 Trial of STA-4783 in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects with Stage IV Metastatic Melanoma - ND

• Conditions: Stage IV Metastatic Melanoma; MedDRA version: 6.1Level: PTClassification code 10027480

• Registration Number: EUCTR2007-001421-10-IT
• Lead Sponsor: SYNTA PHARMACEUTICALS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

1. Must be at least 18 years of age 2. If female of childbearing potential or male, willing to use two forms of effective contraception during study treatment 3. Must have histologically confirmed melanoma of cutaneous origin 4. Must have Stage IV melanoma 5. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 2 (Appendix I) 6. Must have measurable disease according to modified RECIST 7. If subject has received prior systemic therapy, must have evidence of persistent or progressive disease or the inability to tolerate previous treatment due to toxicity, in the opinion of the Investigator 8. Must not have received any prior cytotoxic chemotherapeutic agent for melanoma (eg, DTIC, carmustine, taxanes, microtubule inhibitors) 9. Must not have received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma 10. At least 4 weeks must have passed between the last immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment (excluding anti-CTLA4) and the first dose of study medication 11. At least 8 weeks must have passed between the last treatment with anti-CTLA4 and the first dose of study medication 12. At least 2 weeks must have passed between the last radiotherapy treatment and the first dose of study medication. There must be measurable disease outside the radiotherapy fields or progression of the target lesions within the field since the completion of the radiotherapy 13. Must have a life expectancy of greater than 12 weeks 14. Must have clinical laboratory values at screening as defined below: LDH  2.0 x ULN Hemoglobin 8 g/dL Absolute neutrophil count 1500/mm3 Platelet count 100,000/mm3 Creatinine 1.5 mg/dL (NOTE: If creatinine is >1.5 mg/dL, subject is eligible if creatinine clearance 60 mL/min using the Cockgroft-Gault equation) Total bilirubin 1.5 mg/dL Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) 2.5 x ULN 15. Must have ability to understand and the willingness to sign a written informed consent document
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

1. Female subjects who are pregnant or nursing 2. Presence or history (5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ 3. 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 4. Presence of a potentially drug-induced peripheral neuropathy that is assessed as Grade 3 or greater based on the NCI CTCAE criteria 5. History of or clinical symptoms of central nervous system metastases 6. Presence of any brain metastases (as determined by contrast computed tomography [CT] or magnetic resonance imaging [MRI] scan performed during screening) 7. Presence of clinically significant cardiac arrhythmias 8. Needs chronic immunosuppressive therapy (eg, cyclosporine following transplantation) 9. 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 10. 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 11. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified