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Sponsored by: |
Exelixis |
Information provided by: | Exelixis |
ClinicalTrials.gov Identifier: | NCT00704392 |
The purpose of this study is to determine the safety, tolerability, and highest safe doses of XL647 in combination with XL147 in adults with solid tumors. XL647 is a small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), and ErbB2. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells.
Condition | Intervention | Phase |
Cancer Non-Small-Cell Lung Cancer Breast Cancer |
Drug: XL647 Drug: XL147 |
Phase I |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer Lung Cancer |
ChemIDplus related topics: | Gelatin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL647 and XL147 Administered in Combination Daily to Subjects With Solid Tumors |
Estimated Enrollment: | 68 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: XL647
Tablets supplied at 50-mg strength administered orally daily
Drug: XL147
Gelatin capsules supplied at 25-mg and 100-mg strengths administered orally daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects in the MTD Expansion Cohort:
Exclusion Criteria:
The subject has any of the following cardiac criteria:
United States, New York | |||||
Memorial Sloan Kettering Cancer Center | Recruiting | ||||
New York City, New York, United States, 10021 | |||||
Contact: Lauren Cane 646-227-2136 | |||||
Principal Investigator: Gary Schwartz, MD | |||||
United States, Texas | |||||
South Texas Accelerated Research Therapeutics | Recruiting | ||||
San Antonio, Texas, United States, 78229 | |||||
Contact: Cally Claiborne 210-593-5272 | |||||
Principal Investigator: Kyriakos Papadopoulos, MD |
Exelixis |
Responsible Party: | Exelixis, Inc. ( Ronald Shazer, MD/Associate Director, Clinical Research ) |
Study ID Numbers: | XL647-003 |
First Received: | June 20, 2008 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00704392 |
Health Authority: | United States: Food and Drug Administration |
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