Phase 1 Study of OSI-930 in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00513851
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : September 27, 2011
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
Open label, phase 1, dose escalation

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: OSI-930 Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of Daily Oral OSI-930 in Patients With Advanced Solid Tumors
Study Start Date : April 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: 1
Once Daily Dosing
Drug: OSI-930
Oral OSI-930 administered once daily at increasing doses until disease progression or unacceptable toxicity

Experimental: 2
Twice Daily Dosing
Drug: OSI-930
Oral OSI-930 administered twice daily at increasing doses until disease progression or unacceptable toxicity

Primary Outcome Measures :
  1. 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 [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. Safety, Pharmacokinetic profile, Pharmacodynamic relationships, Preliminary antitumor activity [ Time Frame: 2.5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00513851

United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United Kingdom
Cancer Research UK Professor of Medical Oncology
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Astellas Pharma Inc
OSI Pharmaceuticals

Responsible Party: Astellas Pharma Inc Identifier: NCT00513851     History of Changes
Other Study ID Numbers: OSI-930-102
First Posted: August 9, 2007    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011

Keywords provided by Astellas Pharma Inc:
Advanced Cancer
Non-small cell lung cancer
Small cell lung cancer
Uterine cancer
Ovarian cancer
Renal cancer
Head and neck cancer
Cervical cancer
Metastatic cancer
Colorectal cancer
Gastrointestinal stromal tumors