Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients
NCT00437372
ABOUT THIS STUDY
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Pfizer Clinical Trials Contact Center
1-800-718-1021
- Minimum 2 week course of radiation therapy
- Solid tumors of the central nervous system, head and neck, thorax, and pelvis
- Major surgery or radiation therapy within 4 weeks starting study treatment
- Grade 3 hemorrhage within 4 weeks
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Descriptive Information | ||||
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Brief Title ICMJE | Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients | |||
Official Title ICMJE | A Phase IB, Open-Label, Safety Study of the Combination of Sunitinib and Radiation for the Treatment of Patients With Cancer | |||
Brief Summary | This study is using the combination of radiation and antiangiogenic agents (agents that destroy existing blood vessels) seems to be an approach to tumor cure. | |||
Detailed Description | The combination of ionizing radiation and antiangiogenic agents seems to be a counterintuitive approach to tumor cure because oxygen is a potent radiosensitizer and a reduction in oxygen concentration would be expected following a reduction in tumor vasculature after antiangiogenic treatment. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Sunitinib plus Radiation
Sunitinib plus Radiation Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 39 | |||
Original Enrollment ICMJE | 27 | |||
Actual Study Completion Date ICMJE | December 2010 | |||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00437372 | |||
Other Study ID Numbers ICMJE | 06C.549 2006-30 ( Other Identifier: CCRRC ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ) | |||
Study Sponsor ICMJE | Sidney Kimmel Cancer Center at Thomas Jefferson University | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Thomas Jefferson University | |||
Verification Date | October 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |