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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: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| 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: | August 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Dose-escalation
|
Drug: ENMD-2076
Capsules, daily dosing in 28 day cycles
|
|
2: Experimental
Advanced cancer, excluding patients with colorectal or ovarian cancers
|
Drug: ENMD-2076
Capsules, daily dosing in 28 day cycles
|
|
3: Experimental
Recurrent or resistant epithelial ovarian cancer
|
Drug: ENMD-2076
Capsules, daily dosing in 28 day cycles
|
|
4: Experimental
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: | EntreMed, Inc. ( Chief Medical Officer ) |
| Study ID Numbers: | 2076-CL-001 |
| Study First Received: | April 11, 2008 |
| Last Updated: | January 4, 2010 |
| ClinicalTrials.gov Identifier: | NCT00658671 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Neoplasms |