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A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Hematological Malignancies

Phase 1
18 Years
Not Enrolling
Relapsed or Refractory Hematological Malignancies

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Trial Information

A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Hematological Malignancies

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Define the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of oral daily ENMD 2076 by evaluation of adverse events

Outcome Time Frame:

Day 1 through first cycle of therapy

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

May 2011

Related Keywords:

  • Relapsed or Refractory Hematological Malignancies
  • Leukemia
  • Hematologic neoplasms
  • Neoplasms
  • Hematologic Neoplasms