Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT01300962
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMK120 — DRUG
    BKM120 PO 50, 80 or 100mg every day for each day of each 21 day cycle. Number of cycles: until progression of disease; unacceptable toxicity, withdrawal or death.
  • Capecitabine — DRUG
    875-1250mg/m2 PO BID for two weeks followed by one week rest every three week cycle. Number of cycles: until progression of disease, unacceptable toxicity, withdrawal or death.
  • BYL719 — DRUG
    BYL719 200mg PO BID for 21 days (3 weeks) in combination with capecitabine 1000 mg/m2 PO BID for 2 weeks
  • Trastuzumab — DRUG
    trastuzumab infusion on day 1 of each cycle.
  • Lapatinib — DRUG
    lapatinib daily for 21 days in each cycle.

Study Details

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).

Key Dates

Start date
Aug 31, 2011
Status verified
Nov 2023
Primary completion
Feb 7, 2017
Completion
Dec 31, 2018

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BYL719 ARM B
    Treatment with BYL719 and Capecitabine
  • Experimental: BKM120 ARM A
    Treatment with BKM120 and capecitabine
  • Experimental: ARM C
    BKM 120 plus capecitabine plus trastuzumab
  • Experimental: ARM D
    BKM120 plus capecitabine plus lapatinib

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: two years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Duke Comprehensive Cancer CenterDurhamNorth Carolina27710-

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Lineberger Comprehensive Cancer Center· Chapel Hill, NCDuke Comprehensive Cancer Center· Durham, NC

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