Phase I Study of OSI-930 and Erlotinib in Cancer Tumors

NCT ID: NCT00603356

Last Updated: 2011-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-07-31

Brief Summary

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

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Dose Escalation

Group Type: EXPERIMENTAL

OSI-930 and erlotinib

Intervention Type: DRUG

OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity

Interventions

OSI-930 and erlotinib

OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity

Intervention Type: DRUG

Eligibility Criteria

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 EGFR 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 inability to take oral medications, required for IV alimentation
• Clinically significant ophthalmologic abnormalities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OSI Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

The Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

Countries

United States; United Kingdom

Other Identifiers

OSI-930-103

Identifier Type: -

Identifier Source: org_study_id