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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: September 12, 2005
Last updated: December 10, 2015
Last verified: December 2015
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

Condition Intervention Phase
Drug: Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of MS-275, a Histone Deacetylase Inhibitor, Comparing 2 Dosage Schedules in Patients With Metastatic Melanoma

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Overall tumor response rate (the proportion of subjects with the best tumor response of PR or CR within the first 6 cycles of treatment) [ Time Frame: Baseline, 8, 16, 24, 32 weeks (cycle 6) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to tumor progression [ Time Frame: Baseline, every 8 weeks until progression ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Tumor response rate at each tumor assessment time point (CR/PR/SD/PD/not assessable) [ Time Frame: At baseline and repeated every 2 cycles until tumor progression between Day 22 of even numbered cycles and Day 1 of subsequent odd numbered cycle and also at EOT and F-up visiit (90 days after the EOT and every 3 months until disease progression) ] [ Designated as safety issue: No ]
  • Time to death [ Time Frame: Baseline, every 8 weeks until death ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Approximately 8-64 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: December 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)
MS-275, 3 mg on Days 1 and 15 of a 4-week cycle
Experimental: 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
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00185302

Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00185302     History of Changes
Other Study ID Numbers: 91410  2004-002395-41  309100 
Study First Received: September 12, 2005
Last Updated: December 10, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Non-resectable metastatic melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on October 21, 2016