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Clinical Trials >> A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors
Mesothelioma Related Clinical Trials:
A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors
Status: Recruiting
Sponsors and Collaborators: OSI Pharmaceuticals
Information provided by: OSI Pharmaceuticals
Government Identifier: NCT00603356
Condition: Advanced Solid Tumors
Intervention: Drug: OSI-930 and erlotinib
Purpose:
This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.
| 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 |
Further study details as provided by OSI Pharmaceuticals:
Primary Outcome Measures:
- Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety, evaluate pharmacodynamic relationships [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
| 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 |
| 1: Experimental
Dose Escalation |
Drug: OSI-930 and erlotinib
OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity |
Detailed Description:
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 |
Criteria
Inclusion Criteria:
- Age greater than or equal to 18 years.
- ECOG PS less than or equal to 2
- Predicted life expectancy greater than 12 weeks
- Histologically or cytologically documented advanced solid tumor.
- Adequate hematopoietic, hepatic, and renal function ECOG PS less than or equal to 2
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603356Contacts
| 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 | Not yet recruiting | ||||
| Tampa, Florida, United States, 33612 | |||||
| Contact: OSIP Medical Informaiton 800.572.1932, x7821 medical-information@osip.com | |||||
| United Kingdom | |||||
| The Beatson West of Scotland Cancer Centre | Recruiting | ||||
| Glasgow, United Kingdom, G12 0YN | |||||
| Contact: OSIP Medical Informaiton 800.572.1932, x7821 medical-information@osip.com | |||||
Sponsors and Collaborators
| OSI Pharmaceuticals |
Additional Information:
| Responsible Party: | OSI Pharmaceuticals, Inc. ( Karsten Witt, MD, VP Clinical Development ) |
| Study ID Numbers: | OSI-930-103 |
| First Received: | December 26, 2007 |
| Last Updated: | January 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00603356 |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by OSI Pharmaceuticals:
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Study placed in the following topic categories:
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Additional relevant MeSH terms:
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