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Study of the Safety and Pharmacokinetics of XL765 in Adults With Solid Tumors
This study is currently recruiting participants.
Study NCT00485719   Information provided by Exelixis
First Received: June 11, 2007   Last Updated: October 20, 2008   History of Changes

June 11, 2007
October 20, 2008
June 2007
December 2009   (final data collection date for primary outcome measure)
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 ]
Safety, tolerability, and maximum tolerated dose of daily oral administration of XL765 in subjects with solid tumors
Complete list of historical versions of study NCT00485719 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Plasma pharmacokinetics of daily oral administration of XL765 in subjects with solid tumors
  • Pharmacodynamic effects of XL765 on tumor tissue when administered at the maximum tolerated dose
 
Study of the Safety and Pharmacokinetics of XL765 in Adults With Solid Tumors
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL765 Administered Orally Daily to Subjects With Solid Tumors

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.

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Cancer
Drug: XL765
  • Experimental: Twice daily (bid) dosing
  • Experimental: Once daily (qd) dosing
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
75
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Exelixis Contact Line 1-866-939-4041
United States,   Spain
 
NCT00485719
Ron Shazer, MD/Director, Clinical Research, Exelixis
XL765-001
Exelixis
 
 
Exelixis
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP