Phase I Study of OSI-930 and Erlotinib in Cancer Tumors

A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors

This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.

Study Overview

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

Detailed Description

Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose of OSI-930 and Erlotinib.

Patients may continue to receive OSI-930 and Erlotinib 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
  • Glasgow, United Kingdom, G12 0YN
    • The Beatson West of Scotland Cancer Centre
• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histology 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 greater than or equal to 18 years
• ECOG PS 0-2
• ANC greater than or equal to 1.5 x 10^9/L
• Bilirubin less than or equal to 1.5 x upper limit of normal (ULN), AST and ALT less than or equal to 2.5 x ULN
• Creatinine less than or equal to 1.5 ULN
• Predicted life expectancy greater than or equal to 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)
• Prior surgery is permitted, provided that wound healing has occurred prior to registration
• Patients must use proactive effective contraceptive measures throughout the study
• Provide written informed consent
• Accessible for repeat dosing and follow-up
• Adequate hematopoietic, hepatic, and renal function

Exclusion Criteria:

• Significant cardiac disease unless well controlled
• Current or former smokers, unless patients stopped smoking greater than 3 months prior to registration
• Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation
• History of unacceptable toxicity with previous EGFR inhibitor therapy
• History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate
• Use of CYP3A4 inducers/inhibitors during the 14 days prior to first dose
• Pregnant or breast-feeding females
• 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
• GI abnormalities including inability to take oral medications, required for IV alimentation
• Clinically significant ophthalmologic abnormalities

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

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Dose Escalation	Drug: OSI-930 and erlotinib; OSI-930 administered daily in combination with Erlotinib 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), evaluate the pharmacokinetic profiles	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety, evaluate pharmacodynamic relationships	18 months

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: OSI Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: December 26, 2007
• First Submitted That Met QC Criteria: January 28, 2008
• First Posted (Estimate): January 29, 2008

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: Cancer; NSCLC; Colorectal Cancer; Ovarian Cancer; Sarcoma; Mesothelioma; GIST; Renal
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: OSI-930-103