A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma
Information source: Merck
Information obtained from ClinicalTrials.gov on August 07, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months (Drug)
Phase: Phase 1
Status: Terminated
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
The purposes of this study are:
- To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i. e., first 6 weeks) in patients with advanced multiple myeloma;
- To assess the safety and overall response rate to SAHA in patients with advanced multiple myeloma.
Clinical Details
Official title:
Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma
Study design: Interventional, Treatment, Non-Randomized, Open Label
Primary outcome: PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma.PHASE II: Safety and overall response rate to SAHA in patients with advanced multiple myeloma.
Secondary outcome: 1) Anti-tumor activity in patients with advanced multiple myeloma; 2) Biological effects of SAHA in peripheral mononuclear cells and bone marrow plasma cells; 3) Correlation of biological effects of SAHA with serum drug concentration.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG)
- Adequate bone marrow reserve
- Adequate hepatic and renal function
- Ability to swallow capsules
- 3 weeks or more from prior chemotherapy and have recovered from prior toxicities
Exclusion Criteria:
- Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment
- Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism
- Patients with other active/uncontrolled clinically significant illnesses
- Pregnant or nursing female patients
Locations and Contacts
Call for Information, Boston, Massachusetts 02115-6084, United States
Call for Information, Hackensack, New Jersey 07601, United States
Call for Information, Fairfax, Virginia 22031, United States
Additional Information
Starting date:
December 2003
Last updated: May 17, 2006
|
