Phase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1)
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Standard of care:
Treatment with Trastuzumab
Experimental:
21-Day Cycle of Combination therapy with T-DM1 intravenously on Day 1 and oral PD-0332991 on
Days 5-18
Study Design and Methodology:
This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with
T-DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior
trastuzumab or other HER2-directed therapies.
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)
The 3+3 design entails that if one patient out of the first three patients has a DLT, up to
three additional patients will be entered at that dose level
Treatment cycles will continue until disease progression or withdrawal from study.
Phase:
Phase 1
Details
Lead Sponsor:
Barbara Haley University of Texas Southwestern Medical Center