check_circleStudy Completed

Melanoma

Safety and efficacy study of a new chemotherapy agent to treat metastatic melanoma

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal
28
Trial Dates
December 2004 - July 2006
Phase
Phase 2
Could I Receive a placebo
No
Products
Histone Deacetylase Inhibitor MS-275 (BAY86-5274)
Accepts Healthy Volunteer
No

Primary Outcome

  • Overall tumor response rate (the proportion of subjects with the best tumor response of PR or CR within the first 6 cycles of treatment)
    date_rangeTime Frame:
    Baseline, 8, 16, 24, 32 weeks (cycle 6)
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    Safety Issue:
    no

Secondary Outcome

  • Time to tumor progression
    date_rangeTime Frame:
    Baseline, every 8 weeks until progression
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    Safety Issue:
    no
  • Survival
    date_rangeTime Frame:
    At 6 months
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    Safety Issue:
    no
  • Tumor response rate at each tumor assessment time point (CR/PR/SD/PD/not assessable)
    date_rangeTime 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)
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    Safety Issue:
    No
  • Time to death
    date_rangeTime Frame:
    Baseline, every 8 weeks until death
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    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 8-64 weeks
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    Safety Issue:
    Yes

Trial design

Phase II study of MS-275, a histone deacetylase inhibitor, comparing 2 dosage schedules in patients with metastatic melanoma
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2