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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sanofi
Study ID
NCT00777699
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XL765 (SAR245409) — DRUG
    Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths; daily dosing
  • erlotinib — DRUG
    Tablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing

Study Details

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.

Key Dates

First listed
Oct 22, 2008
Start date
Aug 31, 2008
Status verified
Feb 2012
Primary completion
Feb 28, 2011
Completion
Feb 28, 2011

Study Design

Enrollment
80 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational Site Number 168983PhiladelphiaPennsylvania19111-

Find similar trials in Philadelphia, PA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Investigational· Philadelphia, PA

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