Phase 1 Study of OSI-930 in Cancer Patients

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

Open label, phase 1, dose escalation

Key facts

Study ID

NCT00513851

Run by

Astellas Pharma Inc

People needed

60

Starts

2006-04-01

Expected to finish

2009-09-01

Last updated by the study team

2011-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically 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 >/= 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.

You may not qualify if…

• 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. 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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