drugset / Trial / NCT01300962
Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer
Phase 1
Completed
47 enrolled
UNC Lineberger Comprehensive Cancer Center
Novartis Pharmaceuticals · collab
Non-randomizedSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2011-08
- Primary completion
- 2017-02-07
- Completion
- 2018-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpelisib | Small molecule | 200 mg | Oral |
| Subject | Buparlisib | Small molecule | 50 mg | Oral |
| Subject | Buparlisib | Small molecule | 80 mg | Oral |
| Subject | Buparlisib | Small molecule | 100 mg | Oral |
| Subject | Capecitabine | Small molecule | 875 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Subject | Lapatinib | Small molecule | — | Oral |
| Subject | Trastuzumab | Monoclonal antibody | — | Intravenous |