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| Sponsor: | EntreMed |
|---|---|
| Information provided by: | EntreMed |
| ClinicalTrials.gov Identifier: | NCT00904787 |
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 I |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 |
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Leukemia Hematologic neoplasms |
|
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases |