This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.
This is a multicenter, open label, continuous Phase 1b study in patients with MBC. This study will have a dose escalation and expansion. The dose escalation will identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole. The expansion will estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole and the combination of gedatolisib plus palbociclib/fulvestrant.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
141
Gedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.
Palbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.
Letrozole at 2.5 mg daily
Number of participants with dose limiting toxicities
Time frame: up to 28 days
Objective response rate observed in patients in the dose expansion portion
Number of patients for each response category, objective response rate (number of patients with a complete response (CR)) relative to the number of response evaluable patients
Time frame: 16 weeks
Objective response rate observed in patients in the dose expansion portion
Number of patients for each response category, objective response rate (number of patients with a partial response (PR)) relative to the number of response evaluable patients)
Time frame: 16 weeks
Tumor response observed in patients in the dose escalation portion
Time frame: 16 weeks
Duration of response
Time frame: 16 weeks
QTc interval (corrected QT interval)
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle.
Time frame: Screening up to 6 months
Maximum observed plasma concentration
Time frame: Day 1: 0, 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 24, 72 and 168 hours. Cycle 2 Day 1: 0, 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 24, 72 and 168 hours
Progression free survival
Time frame: 16 weeks
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Fulvestrant administered intramuscularly at 500 mg on Day 1, 15 and 28 and then every 28 days.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.
Corona, California, United States
Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, United States
Keck Hospital of USC - Norris Healthcare Center (HC3)
Los Angeles, California, United States
Keck Hospital of USC
Los Angeles, California, United States
LAC+USC Medical Center
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center / Investigational Drug Services
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.
Riverside, California, United States
...and 31 more locations