Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00777699
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : February 3, 2012
Information provided by (Responsible Party):

October 20, 2008
October 22, 2008
February 3, 2012
August 2008
February 2011   (Final data collection date for primary outcome measure)
Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with erlotinib [ Time Frame: Assessed during periodic visits ]
Same as current
Complete list of historical versions of study NCT00777699 on Archive Site
  • To evaluate plasma pharmacokinetics of XL765 and erlotinib when administered in combination [ Time Frame: Assessed during periodic visits ]
  • 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 ]
Same as current
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Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors
A Phase 1 Dose-Escalation Study of XL765 in Combination With Erlotinib in Subjects With Solid Tumors
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.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cancer
  • Non-Small Cell Lung Cancer
  • Drug: XL765 (SAR245409)
    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
    Other Name: Tarceva®
Experimental: 1
  • Drug: XL765 (SAR245409)
  • Drug: erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2011
February 2011   (Final data collection date for primary outcome measure)

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, 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 and an HgbA1c > 7%
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
2008-003219-11 ( EudraCT Number )
XL765-003 ( Other Identifier: (other study code) )
Not Provided
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Study Director: Clinical Sciences & Operations Sanofi
February 2012

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