Trial Condition(s):
Safety and efficacy study of a new chemotherapy agent to treat metastatic melanoma
91410
Not Available
Primary objective: To evaluate the efficacy of two different dosing schedules of MS-275 in subjects with metastatic melanoma
Secondary objectives: To evaluate the safety and to assess the pharmacokinetic profile of MS-275 in subjects with metastatic melanoma
- Adult subjects with Stage III or IV non-resectable nonuveal (cutaneous or mucosal) metastatic melanoma who had received at least one but no more than two previous systemic therapies (immunotherapy and/or chemotherapy) for metastatic disease and who had not responded to or who had progressed after their most recent therapy were eligible for enrollment - Presence of at least one lesion fulfilling the minimum Response Evaluation Criteria in Solid Tumors (RECIST) size requirements for a target lesion - Use of highly effective birth control methods in females of child-bearing potential - Able to undergo either contrast enhanced computed tomography (CT) scan or contrast enhanced magnetic resonance imaging (MRI) scan for tumor assessment - Life expectancy greater than 3 months - Adequate organ and bone marrow functions as defined below: absolute neutrophil count ≥ 1500 /µL, platelets ≥ 100,000 /µL, creatinine ≤ 1.5 × upper limit of normal (ULN) or measured creatinine clearance of ≥ 60 mL/min x 1.73 m2 body surface area, total bilirubin ≤ 1.5 times ULN, aspartate aminotransferase or serum glutamic oxalacetic transaminase/alanine aminotransferase or serum glutamic pyruvic transaminase∗ ≤ 2.5 times ULN - Negative serum pregnancy test within 2 weeks prior to receiving the first dose of study drug in female subjects of childbearing potential. Agreement to use a highly effective method of birth control throughout the study period and 3 months thereafter for sexually active males and females of childbearing potentia
- Active malignancy in the last five years - Pregnancy, breast feeding - HIV infection - Brain metastasis - Concomitant use of corticosteroids or valproic acid - Uncontrolled intercurrent illness - Diagnosis of uveal melanoma - Eastern Cooperative Oncology Group performance status ≥ 2 - Ongoing effects from previous investigational drug studies or concomitant participation in other investigational drug studies - Prior use of MS-275 or any other HDAC inhibitor - History of allergic reactions attributed to compounds of similar chemical or biologic composition to MS-275 - Anticancer therapy - Active gastrointestinal conditions that might predispose for poor drug absorption - Major surgery within 4 weeks prior to enrollment - Hypophosphatemia < 2.5 mg/dL at screening, if not corrected in the screening period - Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
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Phase II study of MS-275, a histone deacetylase inhibitor, comparing 2 dosage schedules in patients with metastatic melanoma
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2