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Sponsored by: |
OSI Pharmaceuticals |
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Information provided by: | OSI Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00739453 |
Multicenter, open-label, phase 1, cohort dose escalation study to determine the MTD of OSI-906 in combination with erlotinib
Condition | Intervention | Phase |
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Advanced Solid Tumors |
Drug: OSI-906 and/or erlotinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase I Dose-Escalation Study of OSI-906 and Erlotinib (Tarceva®) in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 75 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Schedule 1 (S1): OSI-906 is administered on Days 1-3 every 7 days. Erlotinib will be administered daily starting on Day 2.
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Drug: OSI-906 and/or erlotinib
Oral OSI-906 and/or erlotinib administered on an intermittent schedule at increasing doses until disease progression or unacceptable toxicity
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2: Experimental
Schedule 2 (S2): OSI-906 is administered daily starting on Day 1 and erlotinib is administered daily starting on Day 2
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Drug: OSI-906 and/or erlotinib
Oral OSI-906 and/or erlotinib administered on a continuous schedule at increasing doses until disease progression or unacceptable toxicity
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The study will open with Schedule 1 (S1), in which OSI-906 is administered on Days 1-3 every 7 days. Erlotinib will be administered daily starting on Day 2. A treatment period is defined as 21 days. Initiation of Schedule 2 (S2), in which OSI-906 is administered daily starting on Day 1 and erlotinib is administered daily starting on Day 2, will occur after observation of clinically significant related toxicity >/= grade 2 in any patient on S1 or after > 2 dose levels in S1 have been examined without evidence of DLT. Once the recommended phase 2 dose has been established for S1 and S2, 3 expansion cohorts of up to 10 evaluable patients each will be opened.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: OSIP Medical Information | 800.572.1932, x7821 | medical-information@osip.com |
United States, Colorado | |
University of Colorado Health Science Center | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: OSIP Medical Information 303-546-7821 medical-information@osip.com | |
United States, Maryland | |
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: OSIP Medical Information 800-572-1932 ext 7821 medical-information@osip.com | |
United States, Michigan | |
Hudson-Webber Cancer Research Center | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: OSIP Medical Information 800-572-1932 ext 7821 medical-information@osip.com | |
United Kingdom | |
University of Oxford Department of Medical Oncology | Recruiting |
Oxford, United Kingdom, OX3 7LJ | |
Contact: OSIP Medical Information 303-546-7821 medical-information@osip.com |
Study Director: | Andrew Stephens, M.D., PhD | OSI Pharmaceuticals |
Responsible Party: | OSI Pharmaceuticals ( Karsten Witt, MD, VP Clinical Development ) |
Study ID Numbers: | OSI-906-103 |
Study First Received: | August 19, 2008 |
Last Updated: | April 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00739453 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Advanced cancer Non-small cell lung cancer Pancreatic cancer Colorectal cancer Prostate cancer |
Erlotinib Lung Neoplasms Pancreatic Neoplasms Non-small Cell Lung Cancer |
Protein Kinase Inhibitors Carcinoma, Non-Small-Cell Lung Prostatic Neoplasms Colorectal Neoplasms |
Erlotinib Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |