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-BE
• Lead Sponsor: Synta Pharmaceuticals Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-29
• Last Update Posted: 7 October 2014

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. There must be measurable disease outside the radiotherapy fields or progression of the target lesions within the field since the completion of the radiotherapy
-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 (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 < or = 1.5 mg/dL (SI units: < or = 137 µmol/L) (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 (SI units: < or = 26 µmol/L)
*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