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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: Completed Phase 1 study of Breast Cancer, sponsored by Genentech.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2009-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT00960960 record still lists
NCT00960960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
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 lists 5 locations in 5 states (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
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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.
Where NCT00960960's enrollment target sits among peer trials
71 693rd of 1224 higher than 530 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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