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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
 Drug: ENMD-2076
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Further study details as provided by EntreMed:

Primary Outcome Measures:
  • Maximum tolerated dose of ENMD-2076 [ Time Frame: Within first 35 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 13
Study Start Date: December 2008
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ENMD-2076
Oral capsules, once daily in 28-day cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806065

Locations
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
EntreMed
  More Information

No publications provided

Responsible Party: Chief Medical Officer, EntreMed, Inc.
ClinicalTrials.gov Identifier: NCT00806065     History of Changes
Other Study ID Numbers: 2076-CL-002
Study First Received: December 9, 2008
Last Updated: January 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013