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

Sponsor:	OSI Pharmaceuticals
Information provided by:	OSI Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00603356

Purpose

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

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: OSI-930 and erlotinib	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by OSI Pharmaceuticals:

Primary Outcome Measures:

Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety, evaluate pharmacodynamic relationships [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	November 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Dose Escalation	Drug: OSI-930 and erlotinib OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603356

Locations

United States, Florida
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN

Sponsors and Collaborators

OSI Pharmaceuticals

More Information

No publications provided

Responsible Party:	OSI Pharmaceuticals, Inc. ( Karsten Witt, MD, VP Clinical Development )
Study ID Numbers:	OSI-930-103
Study First Received:	December 26, 2007
Last Updated:	May 21, 2009
ClinicalTrials.gov Identifier:	NCT00603356 History of Changes
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by OSI Pharmaceuticals:

GIST
Ovarian Cancer
Mesothelioma
Renal

Colorectal Cancer
Sarcoma
NSCLC
Cancer

Additional relevant MeSH terms:

Erlotinib
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 22, 2009