Study of ENMD-2076 in Patients With Multiple Myeloma

CASI Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: ENMD-2076

Study type: Interventional

Funder types: Industry

Identifiers

NCT00806065

2076-CL-002

Details and patient eligibility

About

Safety, tolerability, maximum tolerated dose and clinical benefit of ENMD-2076 administered over a range of doses in patients with relapsed or refractory multiple myeloma.

Full description

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

ENMD-2076

Experimental group

Description:

Oral capsules, once daily in 28-day cycles

Treatment:

Drug: ENMD-2076