Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Melanoma
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185302
First received: September 12, 2005
Last updated: January 22, 2009
Last verified: January 2009
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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 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 Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013