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

This study has been completed.
Sponsor:
Information provided by:
EntreMed
ClinicalTrials.gov Identifier:
NCT00904787
First received: May 19, 2009
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Hematological Malignancies

Resource links provided by NLM:


Further study details as provided by EntreMed:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and toxicity of repeated oral dosing of ENMD 2076 [ Time Frame: Throughout study participation ] [ Designated as safety issue: Yes ]
  • Describe any preliminary evidence of anti-cancer effects of ENMD-2076 in patients with hematological malignancies [ Time Frame: monthly ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: April 2009
Study Completion Date: May 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ENMD-2076
capsule, dose escalation, taken orally, daily in 28 day cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904787

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
EntreMed
  More Information

No publications provided

Responsible Party: Carolyn Sidor, Chief Medical Officer
ClinicalTrials.gov Identifier: NCT00904787     History of Changes
Other Study ID Numbers: 2076-CL-003
Study First Received: May 19, 2009
Last Updated: August 3, 2011
Health Authority: United States: Food and Drug Administration
Canada: Therapeutic Products Directorate

Keywords provided by EntreMed:
Leukemia
Hematologic neoplasms

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014