Safety Study of XL147 (SAR245408) in Combination With Erlotinib in Adults With Solid Tumors

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Sanofi
Study ID
NCT00692640
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • XL147 (SAR245408) — DRUG
    Gelatin capsules supplied in 25-mg and 100-mg strengths; daily dosing for 21 days/7 days off
  • 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 XL147 in combination with erlotinib (Tarceva®) in subjects with solid tumors. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in 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
Jun 6, 2008
Start date
May 31, 2008
Status verified
Mar 2012
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Safety, tolerability, and maximum tolerated dose of XL147 administered in combination with erlotinib [ Time Frame: Assessed during periodic visits ]

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational Site Number 1214NashvilleTennessee37203-

Find similar trials in Nashville, TN

By condition
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By specialty
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By research site
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