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| Sponsor: | EntreMed |
|---|---|
| Information provided by: | EntreMed |
| ClinicalTrials.gov Identifier: | NCT00658671 |
Purpose
A dose-escalation trial designed to assess the safety and tolerability of treatment with ENMD-2076 administered orally over a range of doses in patients with advanced cancer that is refractory to current treatment or for which no curative therapy exists.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer |
Drug: ENMD-2076 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Study of ENMD-2076 Administered Orally to Patients With Advanced Cancer |
| Estimated Enrollment: | 59 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | June 2012 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Dose-escalation
|
Drug: ENMD-2076
Capsules, daily dosing in 28 day cycles
|
|
Experimental: 2
Advanced cancer, excluding patients with colorectal or ovarian cancers
|
Drug: ENMD-2076
Capsules, daily dosing in 28 day cycles
|
|
Experimental: 3
Recurrent or resistant epithelial ovarian cancer
|
Drug: ENMD-2076
Capsules, daily dosing in 28 day cycles
|
|
Experimental: 4
Colorectal cancer patients who have progressed and/or failed on irinotecan- and oxaliplatin-based regimens
|
Drug: ENMD-2076
Capsules, daily dosing 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| United States, Colorado | |
| University of Colorado Hospital | |
| Aurora, Colorado, United States, 80045 | |
| United States, Massachusetts | |
| Dana Farber/Harvard Cancer Center | |
| Boston, Massachusetts, United States | |
More Information
| Responsible Party: | Chief Medical Officer, EntreMed, Inc. |
| ClinicalTrials.gov Identifier: | NCT00658671 History of Changes |
| Other Study ID Numbers: | 2076-CL-001 |
| Study First Received: | April 11, 2008 |
| Last Updated: | January 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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Neoplasms |