Mesothelioma Related Clinical Trials:
A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors

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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

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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.

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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

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603356

Contacts
Contact: OSIP Medical Informaiton     800.572.1932, x7821     medical-information@osip.com    
Contact: Tarceva Medical Information Direct     303-546-7821     medical-information@osip.com    
Locations
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

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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:
GIST  
Ovarian Cancer  
Mesothelioma  
Renal  
Colorectal Cancer
Sarcoma
NSCLC
Cancer

Study placed in the following topic categories:
Erlotinib
Ovarian cancer
Non-small cell lung cancer
Ovarian Neoplasms
Malignant mesenchymal tumor
Sarcoma
Mesothelioma
Soft tissue sarcomas

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

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