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NCT01132664 · ClinicalTrials.gov registry record · Phase 1
Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT01132664: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01132664 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01132664, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab. The study will further assess the safety and preliminary efficacy of BKM120 in combination with trastuzumab and capecitabine in patients with relapsing HER2 overexpressing breast cancer and brain metastases (BM) who have previously failed trastuzumab.
Primary Outcome
Determination of the maximum tolerated dose (MTD) in the dose escalation part of the study was based upon the estimation of the probability of DLT in Cycle 1 in patients of the dose-determining set.
Interventions
- DRUG Trastuzumab
- DRUG Capecitabine
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
Why NCT01132664 stopped before completion
NCT01132664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT01132664 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01132664 about?
NCT01132664 is a clinical study titled "Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer". This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab. The study will further assess the safety and preliminary efficacy of BKM120 in combination with trastuzumab a...
What is the current status of trial NCT01132664?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2010-05. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01132664?
The interventions under investigation include: Trastuzumab (DRUG), Capecitabine (DRUG), BKM120 (DRUG).
Who is sponsoring clinical trial NCT01132664?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01132664's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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