Phase 1 Study of OSI-930 in Cancer Patients

A Phase I Dose Escalation Study of Daily Oral OSI-930 in Patients With Advanced Solid Tumors

Open label, phase 1, dose escalation

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: OSI-930; Drug: OSI-930

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
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Cancer Research UK Professor of Medical Oncology
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Safety, Pharmacokinetic profile, Pharmacodynamic relationships, Preliminary antitumor activity	2.5 years

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: OSI Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: August 7, 2007
• First Submitted That Met QC Criteria: August 8, 2007
• First Posted (Estimate): August 9, 2007

Study Record Updates

• Last Update Posted (Estimate): September 27, 2011
• Last Update Submitted That Met QC Criteria: September 26, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Colorectal cancer; Non-small cell lung cancer; Ovarian cancer; Renal cancer; Advanced Cancer; Head and neck cancer; Small cell lung cancer; Metastatic cancer; Cervical cancer; Gastrointestinal stromal tumors; Uterine cancer
• Other Study ID Numbers: OSI-930-102