Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Melanoma

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Entinostat; Histone Deacetylase Inhibitors

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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