Phase IB Study Using Sunitinib Plus Radiation Therapy for 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: NCT00437372|
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : October 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cancer Head and Neck Cancer Pelvic Cancer Nervous System Neoplasms Thoracic Neoplasms||Drug: Sunitinib Radiation: External Beam Radiation Therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IB, Open-Label, Safety Study of the Combination of Sunitinib and Radiation for the Treatment of Patients With Cancer|
|Study Start Date :||March 2007|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
Experimental: Sunitinib plus Radiation
Sunitinib plus Radiation
The use of the FDA approved drug sunitinib, used in an "off-label" manner with external beam radiation therapy.
Other Names:Radiation: External Beam Radiation Therapy
Radiotherapy will be administered Monday through Friday for a maximum of 8 weeks. Total dose will depend on the patient's disease site.
- To evaluate the safety and toxicity profile of sunitinib when used with concurrent radiation therapy [ Time Frame: 2 years ]The purpose of this study is to determine the safety of the combination of the antiangiogenic, sunitinib, when combined with external beam radiotherapy.
- To measure urine VEGF [ Time Frame: 2 years ]Urine VEGF may be a biomarker of response. This translational approach may be useful to determine who benefits from treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437372
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Adam P Dicker, MD, PhD||Thomas Jefferson University|