Safety Study of XL765 in Combination With Erlotinib in Adults With Solid Tumors - Full Text View

Sponsored by:	Exelixis
Information provided by:	Exelixis
ClinicalTrials.gov Identifier:	NCT00777699

Purpose

The purpose of this study is to evaluate the safety and tolerability of XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors.

XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. Erlotinib is an orally administered inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved by the FDA as a single agent for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and in combination with gemcitabine for first line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Condition	Intervention	Phase
Cancer Non-Small Cell Lung Cancer	Drug: XL765 Drug: erlotinib	Phase I

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Dose-Escalation Study of XL765 in Combination With Erlotinib in Subjects With Solid Tumors

Further study details as provided by Exelixis:

Primary Outcome Measures:

Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with erlotinib [ Time Frame: Assessed during periodic visits ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate plasma pharmacokinetics of XL765 and erlotinib when administered in combination [ Time Frame: Assessed during periodic visits ] [ Designated as safety issue: No ]
To evaluate preliminary efficacy of XL765 in combination with erlotinib in subjects with non-small-cell lung cancer (NSCLC) and other solid tumors [ Time Frame: Assessed during periodic visits ] [ Designated as safety issue: No ]

Estimated Enrollment:	65
Study Start Date:	October 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: XL765 Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths; daily dosing Drug: erlotinib Tablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing

Eligibility

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

Criteria

Inclusion Criteria:

Confirmed diagnosis of:
- Advanced solid tumor that is no longer responding to therapies OR
- Advanced or metastatic NSCLC that has previously been treated with erlotinib or gefitinib
ECOG Performance Status 0-1
Adequate organ and bone arrow function as defined by hematological and serum chemistry limits
At least 18 years old
Both men and women must practice adequate contraception
Informed consent

Exclusion Criteria:

Restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including prior therapy with PI3K, AKT, or mTOR inhibitors, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
Erlotinib intolerant
Taking oral corticosteroids chronically or > 1 mg/day warfarin
Not recovered from the toxic effects of prior therapy
History of diabetes mellitus.
Uncontrolled intercurrent illness
Pregnant or breastfeeding
Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
HIV positive
Diagnosis of another malignancy may exclude subject from study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777699

Contacts

Contact: Exelixis Contact Line

1-866-939-4041

Locations

United States, Pennsylvania
Fox Chase Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19111
Principal Investigator: Roger Cohen, MD
Spain
Hospital General Vall D'Hebron	Recruiting
Barcelona, Spain, 08035
Contact: Enriqueta Felip, MD, PhD +34 629125392 efelip@vhebron.net
Principal Investigator: Enriqueta Felip, MD, PhD

Sponsors and Collaborators

Exelixis

More Information

No publications provided

Responsible Party:	Exelixis, Inc. ( Ronald Shazer, MD/Director, Clinical Research )
Study ID Numbers:	XL765-003
Study First Received:	October 20, 2008
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00777699 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Exelixis:

Cancer
Solid Tumors
NSCLC

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Non-small Cell Lung Cancer
Protein Kinase Inhibitors
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009