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

NCT ID: NCT00185302

Last Updated: 2015-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2006-07-31

Brief 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

Detailed 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.

Conditions

Melanoma

Keywords

Non-resectable metastatic melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Histone Deacetylase Inhibitor, 3 mg

Subjects received 3 mg MS-275 orally biweekly (Days 1 and 15 of a 4 week cycle) or until disease progression or unacceptable toxicity

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

MS-275, 3 mg on Days 1 and 15 of a 4-week cycle

Histone Deacetylase Inhibitor, 7 mg

Subjects received 7 mg MS-275 orally weekly (Days 1, 8, and 15 of a 4 week cycle) until disease progression or unacceptable toxicity

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

MS-275, 7 mg on Days 1, 8 and 15 of a 4-week cycle

Interventions

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

MS-275, 3 mg on Days 1 and 15 of a 4-week cycle

Intervention Type: DRUG

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

MS-275, 7 mg on Days 1, 8 and 15 of a 4-week cycle

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Countries

Germany

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

2004-002395-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

309100

Identifier Type: OTHER

Identifier Source: secondary_id

91410

Identifier Type: -

Identifier Source: org_study_id