Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Melanoma
December 10, 2015 updated by: Bayer
Phase II Study of MS-275, a Histone Deacetylase Inhibitor, Comparing 2 Dosage Schedules in Patients With Metastatic Melanoma
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
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 had progressed after their most recent therapy were eligible for enrollment
- Presence of at least one lesion fulfilling the minimum Response Evaluation Criteria in Solid Tumors (RECIST) size requirements for a target lesion - Use of highly effective birth control methods in females of child-bearing potential
- Able to undergo either contrast enhanced computed tomography (CT) scan or contrast enhanced magnetic resonance imaging (MRI) scan for tumor assessment
- Life expectancy greater than 3 months
- Adequate organ and bone marrow functions as defined below: absolute neutrophil count ≥ 1500 /µL, platelets ≥ 100,000 /µL, creatinine ≤ 1.5 × upper limit of normal (ULN) or measured creatinine clearance of ≥ 60 mL/min x 1.73 m2 body surface area, total bilirubin ≤ 1.5 times ULN, aspartate aminotransferase or serum glutamic oxalacetic transaminase/alanine aminotransferase or serum glutamic pyruvic transaminase∗ ≤ 2.5 times ULN
- Negative serum pregnancy test within 2 weeks prior to receiving the first dose of study drug in female subjects of childbearing potential. Agreement to use a highly effective method of birth control throughout the study period and 3 months thereafter for sexually active males and females of childbearing potentia
Exclusion Criteria:
- Active malignancy in the last five years
- Pregnancy, breast feeding
- HIV infection
- Brain metastasis
- Concomitant use of corticosteroids or valproic acid
- Uncontrolled intercurrent illness
- Diagnosis of uveal melanoma
- Eastern Cooperative Oncology Group performance status ≥ 2
- Ongoing effects from previous investigational drug studies or concomitant participation in other investigational drug studies
- Prior use of MS-275 or any other HDAC inhibitor
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to MS-275
- Anticancer therapy
- Active gastrointestinal conditions that might predispose for poor drug absorption
- Major surgery within 4 weeks prior to enrollment
- Hypophosphatemia < 2.5 mg/dL at screening, if not corrected in the screening period
- Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Histone Deacetylase Inhibitor, 3 mg
Subjects received 3 mg MS-275 orally biweekly (Days 1 and 15 of a 4 week cycle) or until disease progression or unacceptable toxicity
|
MS-275, 3 mg on Days 1 and 15 of a 4-week cycle
MS-275, 7 mg on Days 1, 8 and 15 of a 4-week cycle
|
|
Experimental: Histone Deacetylase Inhibitor, 7 mg
Subjects received 7 mg MS-275 orally weekly (Days 1, 8, and 15 of a 4 week cycle) until disease progression or unacceptable toxicity
|
MS-275, 3 mg on Days 1 and 15 of a 4-week cycle
MS-275, 7 mg on Days 1, 8 and 15 of a 4-week cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall tumor response rate (the proportion of subjects with the best tumor response of PR or CR within the first 6 cycles of treatment)
Time Frame: Baseline, 8, 16, 24, 32 weeks (cycle 6)
|
Baseline, 8, 16, 24, 32 weeks (cycle 6)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to tumor progression
Time Frame: Baseline, every 8 weeks until progression
|
Baseline, every 8 weeks until progression
|
|
Survival
Time Frame: At 6 months
|
At 6 months
|
|
Tumor response rate at each tumor assessment time point (CR/PR/SD/PD/not assessable)
Time 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)
|
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)
|
|
Time to death
Time Frame: Baseline, every 8 weeks until death
|
Baseline, every 8 weeks until death
|
|
Number of participants with adverse events
Time Frame: Approximately 8-64 weeks
|
Approximately 8-64 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
July 1, 2006
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
December 14, 2015
Last Update Submitted That Met QC Criteria
December 10, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 91410
- 2004-002395-41 (EudraCT Number)
- 309100 (Other Identifier: Company ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.