check_circleStudy Completed
Melanoma
Bayer Identifier:
91410
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Secondary objectives: To evaluate the safety and to assess the pharmacokinetic profile of MS-275 in subjects with metastatic melanoma
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
28Trial Dates
December 2004 - July 2006Phase
Phase 2Could I Receive a placebo
NoProducts
Histone Deacetylase Inhibitor MS-275 (BAY86-5274)Accepts Healthy Volunteer
NoPrimary 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)enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Time to tumor progressiondate_rangeTime Frame:Baseline, every 8 weeks until progressionenhanced_encryptionnoSafety Issue:
- Survivaldate_rangeTime Frame:At 6 monthsenhanced_encryptionnoSafety Issue:
- 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)enhanced_encryptionNoSafety Issue:
- Time to deathdate_rangeTime Frame:Baseline, every 8 weeks until deathenhanced_encryptionNoSafety Issue:
- Number of participants with adverse eventsdate_rangeTime Frame:Approximately 8-64 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2Additional Information
Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe.