Expired Study
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Tampa, Florida 33612


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00603356


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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