Phase 1 Study of OSI-930 in Cancer Patients

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: OSI-930

• Registration Number: NCT00513851
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

Open label, phase 1, dose escalation

Detailed Description

Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose on both once daily (QD) and twice daily (BID) schedules.

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-08-07
• Study First Submitted QC: 2007-08-08
• Study First Posted: 2007-08-09
• Primary Completion: 2009-07
• Study Completion: 2009-09
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-26
• Last Update Posted: 2011-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	OSI-930	Once Daily Dosing
2	OSI-930	Twice Daily Dosing

Primary Outcome Measures

Name	Time	Method
Determine the maximum tolerated dose (MTD) for both the once daily (QD) and twice daily (BID) dosing schedules and establish a recommended phase 2 dose of OSI-930	2.5 years

Secondary Outcome Measures

Name	Time	Method
Safety, Pharmacokinetic profile, Pharmacodynamic relationships, Preliminary antitumor activity	2.5 years

Trial Locations

Locations (3)

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

Cancer Research UK Professor of Medical Oncology; 🇬🇧 Sutton, Surrey, United Kingdom

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States