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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: OSI Pharmaceuticals
• Treatments: Erlotinib Hydrochloride

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