Study of Vorinostat (MK0683, SAHA) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma
Information source: Merck
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Suberoylanilide Hydroxamic Acid (SAHA) (Drug); Bortezomib (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
The purposes of this study are:
- To determine the maximum tolerated dose (MTD) for the combination of oral SAHA and
bortezomib in patients with advanced multiple myeloma.
- To assess the safety and tolerability of this regimen and to document the patient's
clinical status (by anti-tumor activity) for this combination, as determined per
standard of care.
Clinical Details
Official title: Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Primary outcome: Maximum tolerated dose (MTD) after 14 consecutive day treatment for 21 day cycles as measured by unacceptable toxicity.
Secondary outcome: Safety and tolerability as measured by disease progression or unacceptable toxicity during each treatment cycle.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult patients with refractory or relapsed multiple myeloma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to
determine patient's ability to perform daily activities)
- Adequate bone marrow reserve
- Adequate hepatic and renal function
- Ability to swallow capsules
- 3 weeks or more since prior chemotherapy and have recovered from prior toxicities
Exclusion Criteria:
- Patients who plan to have a 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 illness
- Pregnant or nursing female patients
- Patients who received bortezomib within 3 months of start of this trial
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Call for Information, Houston, Texas 77030-4009, United States; Recruiting
Additional Information
(MedWatch - FDA maintained medical product safety Information) (PhRMA Clinical Study Results Database - web-based repository for clinical study results) (Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: October 2005
Last updated: August 6, 2008
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