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

Tracking Information
First Received Date ^ICMJE	December 9, 2008
Last Updated Date	January 19, 2012
Start Date ^ICMJE	December 2008
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 9, 2008)	Maximum tolerated dose of ENMD-2076 [ Time Frame: Within first 35 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00806065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 9, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of ENMD-2076 in Patients With Multiple Myeloma
Official Title ^ICMJE	A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Multiple Myeloma
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Multiple Myeloma
Intervention ^ICMJE	Drug: ENMD-2076 Oral capsules, once daily in 28-day cycles
Study Arm (s)	Experimental: 1 Intervention: Drug: ENMD-2076
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	13
Completion Date	January 2012
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00806065
Other Study ID Numbers ^ICMJE	2076-CL-002
Has Data Monitoring Committee	No
Responsible Party	Chief Medical Officer, EntreMed, Inc.
Study Sponsor ^ICMJE	EntreMed
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	EntreMed
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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