This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.

Date First Received: December 26, 2007

Last Updated: April 15, 2008

Verified by: OSI Pharmaceuticals, April 2008

Clinical Trial Phase: Phase 1 Start Date: November 2007

Overall Status: Recruiting

Estimated Enrollment: 60

Brief Summary

Official Title: “A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors”

Condition Keyword(s):

• Advanced Solid Tumors
  
Intervention(s):

• Drug: OSI-930 and erlotinib
  

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

Detailed Clinical Trial 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.

Outcome Measures for this Clinical Trial

Primary:

• Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles 18 months
  

Secondary:

• Safety, evaluate pharmacodynamic relationships 18 months
  

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

• Histology or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists


• Age greater than or equal to 18 years


• ECOG PS 0-2


• ANC greater than or equal to 1.5 x 10^9/L


• Bilirubin less than or equal to 1.5 x upper limit of normal (ULN), AST and ALT less than or equal to 2.5 x ULN


• Creatinine less than or equal to 1.5 ULN


• Predicted life expectancy greater than or equal to 12 weeks


• Prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed


• Prior tyrosine kinase inhibitor therapy is permitted


• Patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration


• Prior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months)


• Prior radiation therapy is permitted provided that it did not exceed 25% of bone marrow reserve and patients have recovered from the toxic effects (a minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive)


• Prior surgery is permitted, provided that wound healing has occurred prior to registration


• Patients must use proactive effective contraceptive measures throughout the study


• Provide written informed consent


• Accessible for repeat dosing and follow-up


• Adequate hematopoietic, hepatic, and renal function
  

Exclusion Criteria:

• Significant cardiac disease unless well controlled


• Current or former smokers, unless patients stopped smoking greater than 3 months prior to registration


• Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation


• History of unacceptable toxicity with previous ECFR inhibitor therapy


• History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate


• Use of CYP3A4 inducers/inhibitors during the 14 days prior to first dose


• Pregnant or breast-feeding females


• Symptomatic brain metastases which are not stable, require steroids, are potentially life-threatening or that have required radiation within the last 28 days


• History of allergic reaction attributed to a similar compound as study drug


• GI abnormalities including ability to take oral medications, required for IV alimentation


• Clinically significant ophthalmologic abnormalities
  

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: OSI Pharmaceuticals

H Lee Moffitt Cancer Center and Research Institute

Tampa Florida 33612 United States

The Beatson West of Scotland Cancer Centre

Glasgow G12 0YN United Kingdom

Overall Clinical Trial Officials and Contacts

Overall Contact: OSIP Medical Informaiton 800.572.1932, x7821 medical-information@osip.com

Additional Information

Information obtained from ClinicalTrials.gov on April 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00603356

Study ID Number: OSI-930-103

ClinicalTrials.gov Identifier: NCT00603356

Health Authority: United States: Food and Drug Administration

Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

Labels: ClinicalTrial