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| Sponsor: | Astellas Pharma Inc |
|---|---|
| Collaborator: |
OSI Pharmaceuticals |
| Information provided by (Responsible Party): | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00603356 |
Purpose
This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: OSI-930 and erlotinib |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Dose Escalation
|
Drug: OSI-930 and erlotinib
OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| H Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United Kingdom | |
| The Beatson West of Scotland Cancer Centre | |
| Glasgow, United Kingdom, G12 0YN | |
More Information
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00603356 History of Changes |
| Other Study ID Numbers: | OSI-930-103 |
| Study First Received: | December 26, 2007 |
| Last Updated: | September 26, 2011 |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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GIST Ovarian Cancer Mesothelioma Renal |
Colorectal Cancer Sarcoma NSCLC Cancer |
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Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |