Study of ENMD-2076 in Patients With Multiple Myeloma

• Sponsor: CASI Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00806065
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arm: 1
• Duration (Months): 37
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: ENMD-2076	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• 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
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: ENMD-2076; Oral capsules, once daily in 28-day cycles

Outcome Measures

Primary Outcome Measures

1. Maximum tolerated dose of ENMD-2076 [Within first 35 days]

Secondary Outcome Measures

1. Correlative studies of activity [throughout the study period]

2. Clinical Benefit [Each cycle of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• CASI Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00806065
• Other Study ID Numbers: 2076-CL-002
• First Posted: Dec 10, 2008
• Last Update Posted: Jan 20, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Jan 20, 2012