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Sponsored by: |
OSI Pharmaceuticals |
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Information provided by: | OSI Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00603356 |
This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.
Condition | Intervention | Phase |
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Advanced Solid Tumors |
Drug: OSI-930 and erlotinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 60 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Dose Escalation
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Drug: OSI-930 and erlotinib
OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity
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Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose of OSI-930 and Erlotinib.
Patients may continue to receive OSI-930 and Erlotinib until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: OSIP Medical Informaiton | 800.572.1932, x7821 | medical-information@osip.com |
Contact: Tarceva Medical Information Direct | 303-546-7821 | medical-information@osip.com |
United States, Florida | |
H Lee Moffitt Cancer Center and Research Institute | Completed |
Tampa, Florida, United States, 33612 | |
United Kingdom | |
The Beatson West of Scotland Cancer Centre | Recruiting |
Glasgow, United Kingdom, G12 0YN | |
Contact: OSIP Medical Informaiton 800.572.1932 ext 7821 medical-information@osip.com |
Responsible Party: | OSI Pharmaceuticals, Inc. ( Karsten Witt, MD, VP Clinical Development ) |
Study ID Numbers: | OSI-930-103 |
Study First Received: | December 26, 2007 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00603356 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
GIST Ovarian Cancer Mesothelioma Renal |
Colorectal Cancer Sarcoma NSCLC Cancer |
Erlotinib Ovarian cancer Non-small cell lung cancer Ovarian Neoplasms Malignant mesenchymal tumor |
Sarcoma Mesothelioma Soft tissue sarcomas Colorectal Neoplasms |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |