Study of ENMD-2076 in Patients With Multiple Myeloma - Full Text View

Sponsored by:	EntreMed
Information provided by:	EntreMed
ClinicalTrials.gov Identifier:	NCT00806065

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 I

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Multiple Myeloma

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 ]

Estimated Enrollment:	30
Study Start Date:	December 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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:

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 Criteria:

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.

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	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Sherif Farag, MD (317) 274-0843 ssfarag@iupui.edu
Principal Investigator: Sherif Farag, MD, PhD, FRACP, FRCPA

Sponsors and Collaborators

EntreMed

More Information

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

Study placed in the following topic categories:

Immunoproliferative Disorders
Hemorrhagic Disorders
Multiple myeloma
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders

Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009