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Study of ENMD-2076 in Patients With Relapsed or Refractory Hematological Malignancies

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. Identifier: NCT00904787
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : August 4, 2011
Information provided by:
CASI Pharmaceuticals, Inc.

Brief Summary:
To define the maximum tolerated dose of oral daily ENMD 2076 in patients with relapsed or refractory hematological malignancies

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Hematological Malignancies Drug: ENMD-2076 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 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 Hematological Malignancies
Study Start Date : April 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Experimental: 1 Drug: ENMD-2076
capsule, dose escalation, taken orally, daily in 28 day cycles

Primary Outcome Measures :
  1. Define the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of oral daily ENMD 2076 by evaluation of adverse events [ Time Frame: Day 1 through first cycle of therapy ]

Secondary Outcome Measures :
  1. Safety and toxicity of repeated oral dosing of ENMD 2076 [ Time Frame: Throughout study participation ]
  2. Describe any preliminary evidence of anti-cancer effects of ENMD-2076 in patients with hematological malignancies [ Time Frame: monthly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have relapsed/refractory hematological malignancy for which no standard therapies are anticipated to result in a durable remission. Patients with poor-risk myelodysplasia (MDS) [i.e., IPSS ≥ 1.5] or chronic myelomonocytic leukemia (CMML) are also candidates for this protocol. Relapsed/refractory leukemias include acute non lymphocytic leukemia (AML) by WHO classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Patients with agnogenic myeloid metaplasia (AMM) are also eligible. Patients with relapsed or refractory lymphoma or myeloma may also participate.
  • Age ≥18 years.
  • Adequate performance status
  • Interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents and adequate recovery from prior toxicities. If the patient had a transplant, at least 6 months must have passed before initiation of treatment on this protocol and stable graft versus host disease (no change in severity) for 4 weeks preceding study entry (if applicable).
  • Persistent clinically significant chronic toxicities from prior therapy must have resolved to baseline or NCI CTCAE Grade < 1
  • Adequate laboratory results within 10 days of ENMD-2076 administration (unless the abnormality is considered attributable to leukemia)

Exclusion Criteria:

  • Pregnant or breast-feeding women.
  • Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy.
  • Impaired cardiac function including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, uncontrolled hypertension, or uncontrolled congestive heart failure. Blood pressure must be < 150/90 at the time of enrollment.
  • Receiving any other treatment for their disease
  • QTc prolongation defined as ≥ 470 ms.

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 identifier (NCT number): NCT00904787

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Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.

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Responsible Party: Carolyn Sidor, Chief Medical Officer Identifier: NCT00904787    
Other Study ID Numbers: 2076-CL-003
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: August 2011
Keywords provided by CASI Pharmaceuticals, Inc.:
Hematologic neoplasms
Additional relevant MeSH terms:
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