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Histone Deacetylase Inhibitor, MS-275

Phase 2

Melanoma | Small molecule | Oncology |Bayer AG|Last Updated: Dec 14, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Histone Deacetylase Inhibitor, MS-275 · 1 trial · 1 indication

Phase 2 1
NCT00185302Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic MelanomaMelanoma
COMPLETED28 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Melanoma
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall tumor response rate (the proportion of subjects with the best tumor response of PR or CR within the first 6 cycles of treatment)
Baseline, 8, 16, 24, 32 weeks (cycle 6)

Secondary Endpoints

Time to tumor progression
Baseline, every 8 weeks until progression
Survival
At 6 months
Tumor response rate at each tumor assessment time point (CR/PR/SD/PD/not assessable)
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)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Histone Deacetylase Inhibitor, 3 mgEXPERIMENTALSubjects received 3 mg MS-275 orally biweekly (Days 1 and 15 of a 4 week cycle) or until disease progression or unacceptable toxicity
Histone Deacetylase Inhibitor, 7 mgEXPERIMENTALSubjects received 7 mg MS-275 orally weekly (Days 1, 8, and 15 of a 4 week cycle) until disease progression or unacceptable toxicity

Interventions

NameTypeDescription
Histone Deacetylase Inhibitor, MS-275 (BAY 86-5274, ZK 244894)DRUGMS-275, 3 mg on Days 1 and 15 of a 4-week cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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 ...

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