Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00960960 · ClinicalTrials.gov registry record · Phase 1

A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer

A Phase 1 study of Breast Cancer, sponsored by Genentech.

Completed
Registry status
Phase 1
Development phase
71
Enrollment target
5
Study locations

NCT00960960 is a Phase 1 study of Breast Cancer that has completed, run by Genentech. The registered enrollment target is 71 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 5 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00960960, a Phase 1 study of Breast Cancer, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 1
Development phase
71 participants
Enrollment target
5
Study locations

Study Summary

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) pictilisib administered with letrozole or intravenous (IV) paclitaxel with and without IV bevacizumab or IV trastuzumab in participants with locally recurrent or metastatic breast cancer. The study consists of three parts. Part 1 (pictilisib will be administered in 21+7 schedule along with paclitaxel and/or bevacizumab), Part 2 (pictilisib will be administered in 5+2 schedule along with paclitaxel and/or bevacizumab or trastuzumab) and Part 3 (pictilisib will be administered in combination with letrozole). Part 1 and Part 2 consists of two stages; a dose escalation stage and a cohort-expansion stage.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Trastuzumab
  • DRUG Bevacizumab
  • DRUG Paclitaxel
  • DRUG Letrozole
  • DRUG Pictilisib

Study Locations (5)

Illinois

  • - Peoria

Massachusetts

  • - Boston

Tennessee

  • - Nashville

Other

  • - Leuven

Lombardy

  • - Milan

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2009-08
Est. Completion 2015-12
Phase Phase 1

Sponsor

Genentech

332 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00960960

The ClinicalTrials.gov registry entry for NCT00960960 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 71 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 (97% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.

NCT00960960 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Illinois, Massachusetts, Tennessee.

Frequently Asked Questions

What is clinical trial NCT00960960 about?

NCT00960960 is a clinical study titled "A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer". This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) pictilisib administered with letrozole or intravenous (IV) paclitaxel with and without IV bevacizumab or IV trastuzumab in participants with locally recurrent or m...

What is the current status of trial NCT00960960?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2009-08. Estimated completion is 2015-12.

What conditions does trial NCT00960960 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00960960?

The interventions under investigation include: Trastuzumab (DRUG), Bevacizumab (DRUG), Paclitaxel (DRUG), Letrozole (DRUG), Pictilisib (DRUG).

Who is sponsoring clinical trial NCT00960960?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00960960 being conducted?

This trial has 5 study locations across Illinois, Massachusetts, Tennessee, Lombardy. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Breast Cancer

All registered trials for this condition

Illinois

All trials with a study site in Illinois

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
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.