A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer (0683-011)(TERMINATED)
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT00126451
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Breast Cancer
- Colorectal Cancer
- Non-small-cell Lung Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) — DRUG
- Duration of Treatment - During each treatment cycle, treatment is administered twice daily for 14 days, followed by 7 days of rest for a total of 10 cycles — DRUG
Study Details
This is an investigational study to determine the response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to oral suberoylanilide hydroxamic acid (SAHA), to evaluate PET as an earlier indicator of response to SAHA as assessed by response evaluation criteria in solid tumours (RECIST) criteria and to evaluate the safety and tolerability of oral suberoylanilide hydroxamic acid.
Key Dates
- Start date
- Dec 1, 2004
- Status verified
- Apr 2017
- Primary completion
- Oct 11, 2005
- Completion
- Oct 11, 2005
Study Design
- Enrollment
- 16 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
Response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to SAHA using RECIST criteria.
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