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NCT00777699 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Cancer and Non-Small Cell Lung Cancer, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
80
Enrollment target
1
Study location

NCT00777699 is a Phase 1 study of Cancer and Non-Small Cell Lung Cancer that has completed, run by Sanofi. The registered enrollment target is 80 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00777699, a Phase 1 study of Cancer and Non-Small Cell Lung Cancer, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 1
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

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.

Interventions

  • DRUG erlotinib
  • DRUG XL765 (SAR245409)

Study Locations (1)

Pennsylvania

  • Investigational Site Number 168983 - Philadelphia

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2008-08
Est. Completion 2011-02
Phase Phase 1

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00777699

The ClinicalTrials.gov registry entry for NCT00777699 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which erlotinib is the first listed.

NCT00777699 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00777699 about?

NCT00777699 is a clinical study titled "Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults 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 ...

What is the current status of trial NCT00777699?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2008-08. Estimated completion is 2011-02.

What conditions does trial NCT00777699 study?

This clinical trial studies the following conditions: Cancer, Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT00777699?

The interventions under investigation include: erlotinib (DRUG), XL765 (SAR245409) (DRUG).

Who is sponsoring clinical trial NCT00777699?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00777699 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.