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

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

Detailed Description
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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.

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

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: OSI-930 and erlotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose Escalation | Drug: OSI-930 and erlotinib<br>* OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, evaluate pharmacodynamic relationships |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GIST, Ovarian Cancer, Mesothelioma, Renal, Colorectal Cancer, Sarcoma, NSCLC, Cancer