Study of ENMD-2076 in Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
EntreMed
ClinicalTrials.gov Identifier:
NCT00806065
First received: December 9, 2008
Last updated: January 19, 2012
Last verified: January 2012

December 9, 2008
January 19, 2012
December 2008
November 2011   (final data collection date for primary outcome measure)
Maximum tolerated dose of ENMD-2076 [ Time Frame: Within first 35 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00806065 on ClinicalTrials.gov Archive Site
  • Correlative studies of activity [ Time Frame: throughout the study period ] [ Designated as safety issue: No ]
  • Clinical Benefit [ Time Frame: Each cycle of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of ENMD-2076 in Patients With Multiple Myeloma
A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Multiple Myeloma

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 relapsed or refractory multiple myeloma.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: ENMD-2076
Oral capsules, once daily in 28-day cycles
Experimental: 1
Intervention: Drug: ENMD-2076
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
January 2012
November 2011   (final data collection date for primary outcome measure)

Major Inclusion Criteria:

  1. Histological evidence of MM and evidence of relapse or refractory disease. Patients with non secretory myeloma or plasmacytoma only will be excluded.
  2. Patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents.
  3. Age ≥18 years.
  4. ECOG performance status 0-2.
  5. Patients must have adequate organ and marrow function

Major Exclusion Criteria:

  1. Prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug ENMD-2076.
  2. Prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis).
  3. Concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
  4. Have unstable angina pectoris or recent myocardial infarction (within 6 months.
  5. Have uncontrolled hypertension or congestive heart failure.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00806065
2076-CL-002
No
Chief Medical Officer, EntreMed, Inc.
EntreMed
Not Provided
Not Provided
EntreMed
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP