EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00328458|
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : March 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Central Nervous System Neoplasms Head and Neck Neoplasms||Drug: EPO906 (epothilone B)||Phase 1|
Thomas Jefferson University has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
- To determine the maximum tolerated dose (MTD) of EPO906 administered in combination with radiation therapy and establish a recommend phase II dose.
- To evaluate the safety and toxicity profile of EPO906 when administered concurrently with radiotherapy in three disease cohorts.
- To evaluate tumor response.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-label, Dose-escalation, Safety Study of the Combination of EPO906 and Radiation Therapy for the Treatment of Patients With Cancer|
|Study Start Date :||February 2004|
|Primary Completion Date :||May 2008|
|Study Completion Date :||July 2009|
- To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of EPO906 when administered to the following patient cohorts who receive 3-7 weeks of radiotherapy
- To evaluate the safety and toxicity profile of EPO906 when administered on a weekly schedule (maximum 7 weeks) concurrently with radiotherapy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328458
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Adam Dicker, MD, PhD||Thomas Jefferson University|