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Study of ENMD-2076 in Patients With Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00806065
First Posted: December 10, 2008
Last Update Posted: January 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
CASI Pharmaceuticals, Inc.
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by CASI Pharmaceuticals, Inc.:

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

Secondary Outcome Measures:
  • Correlative studies of activity [ Time Frame: throughout the study period ]
  • Clinical Benefit [ Time Frame: Each cycle of treatment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806065


Locations
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
  More Information

Responsible Party: Chief Medical Officer, EntreMed, Inc.
ClinicalTrials.gov Identifier: NCT00806065     History of Changes
Other Study ID Numbers: 2076-CL-002
First Submitted: December 9, 2008
First Posted: December 10, 2008
Last Update Posted: January 20, 2012
Last Verified: January 2012

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


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