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| Sponsor: | Syndax Pharmaceuticals |
|---|---|
| Information provided by: | Syndax Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00866333 |
Purpose
This study will evaluate the efficacy and safety of entinostat, SNDX-275, in patients with relapsed or refractory Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin's Lymphoma |
Drug: entinostat (SNDX-275) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 2 Multi-Center Study of Entinostat (SNDX-275) in Patients With Relapsed or Refractory Hodgkin's Lymphoma |
| Estimated Enrollment: | 24 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
treatment: Experimental
entinostat 10 mg (two 5mg tablets) orally, once every two weeks (days 1 and 15) in a 28 day cycle increasing to 15 mg (three 5mg tablets) in absence of treatment related toxicity ≥Grade2 (moderate) beginning Cycle 1 Day 15
|
Drug: entinostat (SNDX-275)
entinostat 10 mg (two 5mg tablets) orally, once every two weeks (days 1 and 15) in a 28 day cycle increasing to 15 mg (three 5mg tablets) in absence of treatment related toxicity ≥Grade2 (moderate) beginning Cycle 1 Day 15
|
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| Contact: Jeannette Hasapidis | 781-419-1404 | jhasapidis@syndax.com |
| United States, California | |
| Tower Cancer Research Foundaton | Recruiting |
| Beverly Hills, California, United States | |
| United States, Colorado | |
| University of Colorado | Recruiting |
| Denver, Colorado, United States | |
| United States, Maryland | |
| Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States | |
| United States, Nebraska | |
| University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States | |
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States | |
More Information
| Responsible Party: | Syndax Pharmaceuticals, Inc. ( Jeannette Hasapidis ) |
| Study ID Numbers: | SNDX-275-0501 |
| Study First Received: | March 19, 2009 |
| Last Updated: | February 2, 2010 |
| ClinicalTrials.gov Identifier: | NCT00866333 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hodgkin's Lymphoma Relapsed Hodgkin's Lymphoma Refractory Hodgkin's Lymphoma |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma Hodgkin Disease |