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

Bayer

Status and phase

Completed

Phase 2

Conditions

Melanoma

Treatments

Drug: Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00185302

2004-002395-41 (EudraCT Number)

91410

309100 (Other Identifier)

Details and patient eligibility

About

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

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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