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Sponsored by: |
Exelixis |
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Information provided by: | Exelixis |
ClinicalTrials.gov Identifier: | NCT00692640 |
The purpose of this study is to evaluate the safety and tolerability of XL147 in combination with erlotinib (Tarceva®) in subjects with solid tumors. 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. Erlotinib is an orally administered inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved by the FDA as a single agent for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and in combination with gemcitabine for first line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Condition | Intervention | Phase |
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Cancer Non-Small Cell Lung Cancer |
Drug: XL147 Drug: Erlotinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 1 Dose-Escalation Study of XL147 in Combination With Erlotinib in Subjects With Solid Tumors |
Estimated Enrollment: | 65 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: XL147
Gelatin capsules supplied in 25-mg and 100-mg strengths; daily dosing for 21 days/7 days off
Drug: Erlotinib
Tablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects accrue to one of two phases:
Exclusion Criteria:
The subject has received:
Contact: Exelixis Contact Line | 1-866-939-4041 |
United States, Michigan | |
Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Erik Troxtel 313-576-8496 | |
Principal Investigator: Patricia LoRusso, DO | |
United States, Tennessee | |
Sarah Cannon Research Institute | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: Narquita Kizzie 615-329-7426 Narquita.Kizzie@scresearch.net | |
Principal Investigator: Howard A. Burris, III, MD |
Responsible Party: | Exelixis, Inc. ( Christian Scheffold, MD/Director, Clinical Research ) |
Study ID Numbers: | XL147-002 |
Study First Received: | June 3, 2008 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00692640 |
Health Authority: | United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency |
Cancer Solid Tumors NSCLC |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |