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

Conditions: Stage IV Metastatic Melanoma
MedDRA version: 9.1Level: LLTClassification code 10027480Term: Metastatic malignant melanoma

Registration Number: EUCTR2007-001421-10-DE

Lead Sponsor: Synta Pharmaceuticals Corp.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 630

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 -must have measurable disease according to modified RECIST
-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
-must not have received any prior cytotoxic chemotherapeutic agent for melanoma (eg, DTIC, carmustine, taxanes, microtubule inhibitors, hyperthermic isolated limb perfusion)
-must not have received more than one regimen of kinase inhibitor, immunotherapy, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma
-at least 4 weeks must have passed between the last kinase inhibitor, immunotherapy, biologic therapy, vaccine or investigational non-chemotherapeutic treatment (excluding anti-CTLA4) and the first dose of study medication
-at least 8 weeks must have passed between the last treatment with anti-CTLA4 and the first dose of study medication
-at least 2 weeks must have passed between the last radiotherapy treatment and the first dose of study medication.
-must have a life expectancy of greater than 12 weeks
-must have clinical laboratory values at screening as defined below:
*LDH < or = to 2.0 x ULN
*Hemoglobin >or = 8g/dL
*Absolute neutrophil count > or = 1500/mm3
*Platelet count > or = to 100,000/mm3
*Creatinine < or = 1.5 mg/dL (NOTE: If creatinine is > 1.5 mg/dL, subject is eligible if
creatinine clearance > or = to 60 mL/min using the Cockgroft-Gault equation)
*Total bilirubin < or = to 1.2 mg/dL
*Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline
phosphatase (ALP) < or = to 2.5 x ULN
-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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>To assess the objective response rate (ORR)<br>To assess the clinical benefit rate (proportion of subjects who have CR or PR, or SD for at least 24 weeks)<br>To assess the duration of objective response<br>To further characterize the safety of STA-4783 in combination with paclitaxel in comparison with paclitaxel alone<br>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)

Secondary Outcome Measures

Name	Time	Method

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