Phase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1)

PHASE1CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

January 24, 2014

Primary Completion Date

May 19, 2021

Study Completion Date

May 19, 2021

Conditions
Advanced Breast Cancer
Interventions
DRUG

PD-0332991 and T-DM1

"The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how well the subject tolerates the treatment.~A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle.~Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral)"

Trial Locations (1)

75390

UT Southwestern Medical Center, Dallas

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

University of Pennsylvania

OTHER

lead

University of Texas Southwestern Medical Center

OTHER