A Four Part, Phase I Dose-Escalation Study of the Combinations of Concurrent BKM120 and Capecitabine, or Concurrent BYL719 and Capecitabine, or Concurrent BKM120 and Capecitabine and Trastuzumab, or Concurrent BKM120 and Capecitabine and Lapatinib in Patients With Metastatic Breast Cancer

NCT01300962 Phase 1 COMPLETED

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).

Details

Lead sponsor	UNC Lineberger Comprehensive Cancer Center
Phase	Phase 1
Status	COMPLETED
Enrolment	47
Start date	2011-08
Completion	2018-12-31

Conditions

• Metastatic Breast Cancer

Interventions

• BMK120
• Capecitabine
• BYL719
• Trastuzumab
• Lapatinib

Primary outcomes

• Maximum Tolerated Dose — two years
  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)
• Dose limiting toxicity (DLT) — two years
  Dose-limiting toxicities (DLT) will be defined per NCI Common Terminology Criteria for Adverse Events version 4 (CTCAE v4)

Countries

United States