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| Sponsor: | Exelixis |
|---|---|
| Information provided by: | Exelixis |
| ClinicalTrials.gov Identifier: | NCT00704392 |
Purpose
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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: 1 |
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
|
Eligibility| 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:
Contacts and Locations| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York City, New York, United States, 10021 | |
| United States, Texas | |
| South Texas Accelerated Research Therapeutics | |
| San Antonio, Texas, United States, 78229 | |
More Information
| Responsible Party: | Ronald Shazer, MD/Associate Director, Clinical Research, Exelixis, Inc. |
| ClinicalTrials.gov Identifier: | NCT00704392 History of Changes |
| Other Study ID Numbers: | XL647-003 |
| Study First Received: | June 20, 2008 |
| Last Updated: | October 20, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Solid tumors NSCLC |
|
Breast Neoplasms Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases |