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

Relapsed or Refractory Hematological Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904787
• Other study ID #: 2076-CL-003
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2009
• Last updated: August 3, 2011
• Start date: April 2009
• Est. completion date: May 2011

Study information

• Verified date: August 2011
• Source: CASI Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Therapeutic Products Directorate
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Neoplasms
• Relapsed or Refractory Hematological Malignancies

Intervention

Drug:
• ENMD-2076
capsule, dose escalation, taken orally, daily in 28 day cycles

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
CASI Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of oral daily ENMD 2076 by evaluation of adverse events		Day 1 through first cycle of therapy	Yes
Secondary	Safety and toxicity of repeated oral dosing of ENMD 2076		Throughout study participation	Yes
Secondary	Describe any preliminary evidence of anti-cancer effects of ENMD-2076 in patients with hematological malignancies		monthly	No