Study of the Safety and Pharmacokinetics of XL765 in Adults With Solid Tumors - Full Text View

Sponsored by:	Exelixis
Information provided by:	Exelixis
ClinicalTrials.gov Identifier:	NCT00485719

Purpose

The purpose of this study is to determine the safety and tolerability of XL765. 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.

Condition	Intervention	Phase
Cancer	Drug: XL765	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

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 the Safety and Pharmacokinetics of XL765 Administered Orally Daily to Subjects With Solid Tumors

Further study details as provided by Exelixis:

Primary Outcome Measures:

Safety, tolerability, and maximum tolerated dose (MTD) of daily oral administration of XL765 in two treatment schedules [ Time Frame: Assessed at each visit/periodic visits ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Plasma pharmacokinetics of daily oral administration of XL765 in two treatment schedules [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
Pharmacodynamic effects of XL765 on tumor tissue when administered at the MTD in two treatment schedules [ Time Frame: Assessed during periodic vixits after MTD is determined ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Twice daily (bid) dosing	Drug: XL765 Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths administered orally
2: Experimental Once daily (qd) dosing	Drug: XL765 Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths administered orally

Eligibility

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

Criteria

Inclusion Criteria:

Histologically confirmed advanced solid tumor that is not responding to standard therapies
ECOG performance status of 0 - 2.
Adequate organ and bone marrow 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 chemotherapy, radiotherapy, cytokines, hormones, nitrosoureas or mitomycin C, and small-molecule kinase inhibitors
Not recovered from the toxic effects of prior therapy
Diagnosis of diabetes
Pregnant or breast feeding
Uncontrolled intercurrent illness
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: NCT00485719

Contacts

Contact: Exelixis Contact Line

1-866-939-4041

Locations

United States, Michigan
Wayne State University Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201
Contact: Theresa Laeder 313-576-9386
Principal Investigator: Patricia LoRusso, DO
United States, Texas
South Texas Accelerated Research Therapeutics	Recruiting
San Antonio, Texas, United States, 78229
Contact: Gina Mangold, MBA 210-413-3594 gmangold@start.stoh.com
Principal Investigator: Kyriakos Papadopoulos, MD
Spain
Hospital Universitario Vall d'Hebron	Recruiting
Barcelona, Spain, 08035
Contact: Gemma Sala +34 93 489 4158 gsala@vhebron.net
Principal Investigator: Jose Baselga, MD, PhD

Sponsors and Collaborators

Exelixis

More Information

No publications provided

Responsible Party:	Exelixis ( Ron Shazer, MD/Director, Clinical Research )
Study ID Numbers:	XL765-001
Study First Received:	June 11, 2007
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00485719 History of Changes
Health Authority:	United States: Food and Drug Administration; Spain: Spanish Agency of Medicines

Keywords provided by Exelixis:

Cancer
Solid Tumors

ClinicalTrials.gov processed this record on May 07, 2009