Phase II Study of MS-275, a Histone Deacetylase Inhibitor, Comparing 2 Dosage Schedules in Patients With Metastatic Melanoma
18 Years
N/A
Both
Melanoma
Trial Information
Phase II Study of MS-275, a Histone Deacetylase Inhibitor, Comparing 2 Dosage Schedules in Patients With Metastatic Melanoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor response rate (complete or partial response according to RECIST)
Outcome Time Frame:
Baseline, 8, 16, 24, 32 weeks (cycle 6)
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
91410
NCT ID:
NCT00185302
Start Date:
December 2004
Completion Date:
July 2006
Related Keywords:
- Melanoma
- Non-resectable metastatic melanoma
- Melanoma
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