Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2006-04-30
2009-09-30
Brief Summary
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Detailed Description
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Patients may continue to receive OSI-930 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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Once Daily Dosing
OSI-930
Oral OSI-930 administered once daily at increasing doses until disease progression or unacceptable toxicity
2
Twice Daily Dosing
OSI-930
Oral OSI-930 administered twice daily at increasing doses until disease progression or unacceptable toxicity
Interventions
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OSI-930
Oral OSI-930 administered once daily at increasing doses until disease progression or unacceptable toxicity
OSI-930
Oral OSI-930 administered twice daily at increasing doses until disease progression or unacceptable toxicity
Eligibility Criteria
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Inclusion Criteria
Age \>/= 18 years, ECOG PS 0-2, life expectancy \>/= 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.
ANC \>/= 1.5 x 10\^9/L, PLT \>/= 100 x 10\^9/L; bilirubin \</= 1.5 x upper limit of normal (ULN), AST and ALT \</= 2.5 x ULN; creatinine \</= 1.5 ULN Accessible for repeat dosing and follow-up. Patients must practice effective contraceptive measures throughout the study. Provide written informed consent.
Exclusion Criteria
History of allergic reaction attributed to a similar compound as study drug. Significant cardiac disease unless well controlled, poorly controlled hypertension.
Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation.
History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate.
Concurrent anticancer therapy. Use of CYP3A4 inducers/inhibitors during the 14 days prior to first dose. Pregnant or breast-feeding females.
18 Years
ALL
No
Sponsors
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OSI Pharmaceuticals
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Locations
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University of Colorado Cancer Center
Aurora, Colorado, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Cancer Research UK Professor of Medical Oncology
Sutton, Surrey, United Kingdom
Countries
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Other Identifiers
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OSI-930-102
Identifier Type: -
Identifier Source: org_study_id