Status:
COMPLETED
Study of ENMD-2076 in Patients With Multiple Myeloma
Lead Sponsor:
CASI Pharmaceuticals, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Safety, tolerability, maximum tolerated dose and clinical benefit of ENMD-2076 administered over a range of doses in patients with relapsed or refractory multiple myeloma.
Detailed Description
The study is designed to assess the safety, tolerability, maximum tolerated dose, and clinical benefit of treatment with ENMD-2076 administered orally once daily over a range of doses in patients with...
Eligibility Criteria
Inclusion
- Major
- Histological evidence of MM and evidence of relapse or refractory disease. Patients with non secretory myeloma or plasmacytoma only will be excluded.
- Patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents.
- Age ≥18 years.
- ECOG performance status 0-2.
- Patients must have adequate organ and marrow function
- Major
Exclusion
- Prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug ENMD-2076.
- Prior radiation therapy to \> 25% of bone marrow forming bones (i.e., pelvis).
- Concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
- Have unstable angina pectoris or recent myocardial infarction (within 6 months.
- Have uncontrolled hypertension or congestive heart failure.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00806065
Start Date
December 1 2008
End Date
January 1 2012
Last Update
February 6 2023
Active Locations (1)
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1
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202