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NCT01042925 · ClinicalTrials.gov registry record · Phase 1

Study of XL147 (SAR245408) in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-based Regimen

A Phase 1 study of Breast Cancer and Breast Neoplasms, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
42
Enrollment target
9
Study locations

NCT01042925 is a Phase 1 study of Breast Cancer and Breast Neoplasms that has completed, run by Sanofi. The registered enrollment target is 42 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 9 study locations across 7 states.

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The verdict

NCT01042925, a Phase 1 study of Breast Cancer and Breast Neoplasms, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 1
Development phase
42 participants
Enrollment target
9
Study locations

Study Summary

Phase 1 of this study will evaluate the maximum tolerated dose (MTD) of XL147 when given in combination with trastuzumab (Herceptin) and in combination with trastuzumab and paclitaxel. After the MTD is established for each combination (Phase 2), subjects will be enrolled to evaluate the preliminary efficacy and safety of these combinations in metastatic HER2 positive breast cancer. Both trastuzumab and paclitaxel are used in the treatment of metastatic breast cancer (MBC), but patients can develop resistance. The link between PI3K mutations and trastuzumab resistance has been seen in breast cancer patients. This suggests that inhibitors of the PI3K/PTEN pathway may have the potential to restore sensitivity to trastuzumab. Similarly, introduction of activated mutant forms of PI3K has been shown to transform and confer paclitaxel resistance to immortalized breast epithelial cells. XL147 is a potent and selective inhibitor of PI3K and inhibits phosphorylation of multiple downstream components of PI3K/PTEN signaling. Therefore, XL147 may have utility in the treatment of trastuzumab resistant/refractory and HER2-positive MBC when administered in combination with trastuzumab alone or with trastuzumab and paclitaxel.

Conditions Studied

Breast Cancer Breast Neoplasms

Interventions

  • DRUG paclitaxel
  • BIOLOGICAL trastuzumab
  • DRUG XL147 (SAR245408)

Study Locations (9)

New York

  • Investigational Site Number 1150 - New York
  • Investigational Site Number 1151 - The Bronx

Tennessee

  • Investigational Site Number 1214 - Nashville
  • Investigational Site Number 1246 - Nashville

California

  • Investigational Site Number 1537 - Los Angeles

Florida

  • Investigational Site Number 1238 - Fort Meyers

Massachusetts

  • Investigational Site Number 1138 - Boston

Michigan

  • Investigational Site Number 1330 - Detroit

Other

  • Investigational Site Number 3413 - Madrid

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2010-02
Est. Completion 2012-12
Phase Phase 1

Sponsor

Sanofi

713 total trials

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What the Registry Record Tells You About NCT01042925

The ClinicalTrials.gov registry entry for NCT01042925 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which paclitaxel is the first listed.

NCT01042925 reports 9 study locations spanning 7 distinct geographic areas - top geographies include New York, Tennessee, California.

Frequently Asked Questions

What is clinical trial NCT01042925 about?

NCT01042925 is a clinical study titled "Study of XL147 (SAR245408) in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-based Regimen". Phase 1 of this study will evaluate the maximum tolerated dose (MTD) of XL147 when given in combination with trastuzumab (Herceptin) and in combination with trastuzumab and paclitaxel. After the MTD is established for each combination (Phase 2), subjects will be enrolled to evaluate the preliminary ...

What is the current status of trial NCT01042925?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2010-02. Estimated completion is 2012-12.

What conditions does trial NCT01042925 study?

This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasms.

What interventions are being tested in trial NCT01042925?

The interventions under investigation include: paclitaxel (DRUG), trastuzumab (BIOLOGICAL), XL147 (SAR245408) (DRUG).

Who is sponsoring clinical trial NCT01042925?

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

Where is trial NCT01042925 being conducted?

This trial has 9 study locations across California, Florida, Massachusetts, Michigan, New York. 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 Editorial

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.