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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185302
First received: September 12, 2005
Last updated: January 22, 2009
Last verified: January 2009
  Purpose

The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic melanoma who have received at least one and no more than two chemotherapies.


Condition Intervention Phase
Melanoma
Drug: MS-275 (BAY86-5274)
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:
  • Tumor response rate (complete or partial response according to RECIST) [ 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 ]
  • Safety (AEs and laboratory values) [ Time Frame: Screening throughout end of study ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: December 2004
Study Completion Date: July 2006
Arms Assigned Interventions
Experimental: Arm 1 Drug: MS-275 (BAY86-5274)
MS-275, 3mg on Days 1 and 15 of a 4-week cycle
Experimental: Arm 2 Drug: MS-275 (BAY86-5274)
MS-275, 7mg 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic melanoma
  • At least one and no more than two chemotherapies
  • Use of highly effective birth control methods in females of child-bearing potential
  • Able to swallow and retain intact investigational drug tablets

Exclusion Criteria:

  • Active malignancy in the last five years
  • Previous participation in another trial within the last 4 weeks
  • Pregnancy, breast feeding
  • HIV infection
  • Brain metastasis
  • Concomitant use of corticosteroids or valproic acid
  • Uncontrolled intercurrent illness
  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 ClinicalTrials.gov identifier: NCT00185302

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

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00185302     History of Changes
Other Study ID Numbers: 91410, EudraCT: 2004-002395-41, 309100
Study First Received: September 12, 2005
Last Updated: January 22, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Non-resectable metastatic melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Entinostat
Histone Deacetylase Inhibitors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014