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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 is a Phase 1 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 47 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01300962
The ClinicalTrials.gov registry entry for NCT01300962 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT01300962 reports 0 study locations.
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.
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