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NCT01300962 · ClinicalTrials.gov registry record · Phase 1
Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer
A Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT01300962: Completed Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT01300962 is a Phase 1 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01300962, a Phase 1 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
This phase I study has been designed to establish the safety, tolerability and maximum tolerated dose (MTD) of four separate regimens for patients with metastatic breast cancer: dose- escalating BKM120 when combined with capecitabine (Arm A), with capecitabine and trastuzumab (Arm C), or with capecitabine and lapatinib (Arm D) and dose- escalating BEZ235 when combined with capecitabine (Arm B).
Primary Outcome
Maximum Tolerated Dose (MTD) will be the highest does at which less than or equal to 1 out of 6 patients have experienced a dose limiting toxicity (DLT)
Interventions
- DRUG Trastuzumab
- DRUG Capecitabine
- DRUG Lapatinib
- DRUG BYL719
- DRUG BMK120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2011-08 |
| Est. Completion | 2018-12-31 |
| Phase | Phase 1 |
What the finished NCT01300962 record still lists
NCT01300962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT01300962 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01300962 about?
NCT01300962 is a clinical study titled "Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer". This phase I study has been designed to establish the safety, tolerability and maximum tolerated dose (MTD) of four separate regimens for patients with metastatic breast cancer: dose- escalating BKM120 when combined with capecitabine (Arm A), with capecitabine and trastuzumab (Arm C), or with capeci...
What is the current status of trial NCT01300962?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2011-08. Estimated completion is 2018-12-31.
What interventions are being tested in trial NCT01300962?
The interventions under investigation include: Trastuzumab (DRUG), Capecitabine (DRUG), Lapatinib (DRUG), BYL719 (DRUG), BMK120 (DRUG).
Who is sponsoring clinical trial NCT01300962?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01300962's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 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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