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NCT00485719 · ClinicalTrials.gov registry record · Phase 1

Study of the Safety and Pharmacokinetics of XL765 (SAR245409) in Adults With Solid Tumors

A Phase 1 study of Cancer, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
83
Enrollment target
4
Study locations

NCT00485719 is a Phase 1 study of Cancer that has completed, run by Sanofi. The registered enrollment target is 83 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT00485719, a Phase 1 study of Cancer, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 1
Development phase
83 participants
Enrollment target
4
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • DRUG XL765 (SAR245409)

Study Locations (4)

Michigan

  • Investigational Site Number 1302 - Detroit

Nebraska

  • Investigational Site Number 1435 - Omaha

Texas

  • Investigational Site Number 1402 - San Antonio

Other

  • Investigational Site Number 3411 - Barcelona

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2007-06
Est. Completion 2012-09
Phase Phase 1

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00485719

The ClinicalTrials.gov registry entry for NCT00485719 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 83 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 1 condition, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which XL765 (SAR245409) is the first listed.

NCT00485719 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Michigan, Nebraska, Texas.

Frequently Asked Questions

What is clinical trial NCT00485719 about?

NCT00485719 is a clinical study titled "Study of the Safety and Pharmacokinetics of XL765 (SAR245409) in Adults 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 i...

What is the current status of trial NCT00485719?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2007-06. Estimated completion is 2012-09.

What conditions does trial NCT00485719 study?

This clinical trial studies the following conditions: Cancer.

What interventions are being tested in trial NCT00485719?

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

Who is sponsoring clinical trial NCT00485719?

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

Where is trial NCT00485719 being conducted?

This trial has 4 study locations across Michigan, Nebraska, Texas. 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.