Breast Cancer Clinical Trial
Official title:
PIPA: A Phase Ib Study to Assess the Safety, Tolerability and Efficacy of the PI3K Inhibitors, Taselisib (GDC-0032) or Pictilisib (GDC-0941), in Combination With PAlbociclib, With the Subsequent Addition of Fulvestrant in PIK3CA-mutant Breast Cancers
Part A: This is a phase Ib trial combining the CDK4/6 inhibitor palbociclib with the PI3K
inhibitors taselisib, or pictilisib. There are two treatment arms during the dose escalation
phase where patients will receive either taselisib OR pictilisib in combination with
palbociclib. Palbociclib, taselisib and pictilisib can all be given orally once daily with
food, in a 21-days-on and 7-days-off schedule. Once the MTD is reached, the combination with
the optimum safety and PK/PD profile will be taken forward to the dose expansion phase (Part
B).
Part B1: At the MTD dose expansion, fulvestrant will be administered in addition to
palbociclib and taselisib or pictilisib orally once daily, in a 21-days-on and 7-days-off
schedule in the ER+ve HER2-ve PIK3CA mutant breast cancer cohort. Fulvestrant will be given
intramuscularly on Day 1, Day 15 in cycle one followed by Day 1 for all subsequent cycles.
Part B2: At the MTD dose expansion, patients with PIK3CA mutant advanced solid tumours will
be treated with palbociclib and taselisib or pictilisib orally once daily, in a 21-days-on
and 7-days-off schedule.
This is a phase Ib trial of palbociclib in combination with either taselisib or pictilisib.
The study will include a dose escalation phase (Part A), and an MTD dose expansion phase
(Part B).
Part A: will investigate escalating doses of palbociclib with either pictilisib or taselisib
administered orally, continuously for 21 days out of a 28 day cycle in patients with advanced
solid tumours recruited simultaneously into two parallel arms (up to 24 patients in each arm
with a maximum of 48 patients in Part A).
Once the MTD is determined the combination with the optimum safety and PK/PD profile as
determined by the SRC will be taken forward to the dose expansion phase (Part B).
Part B: The MTD dose expansion phase will be conducted using the optimal combination from
Part A in two parallel arms as follows:
B1: Patients (n=25) with PIK3CA mutant ER + HER2-ve advanced breast cancers will be treated
with a triplet combination of palbociclib and either taselisib or pictilisib along with
fulvestrant. Part B1 will require at least two of the first 15 patients to respond to
progress to recruit the full 25 patients.
B2: Patients (n=20) with PIK3CA mutant advanced solid tumours including at least 8 patients
with PIK3CA mutant ER negative and/or HER2 positive breast cancers will be treated with the
doublet combination of palbociclib and either taselisib or pictilisib. Other cancers with
relevant genetic aberrations (e.g. KRAS mutations) may be considered, depending on emerging
preclinical and clinical data on these novel antitumour agents.
In total, it is expected that a minimum of 70 and up to a maximum of 93 patients will be
enrolled into the trial, the final number will depend on the number of dose escalations
required to reach DLT. If < 48 patients are enrolled in Part A, investigators will be
permitted to enrol > 45 patients in Part B, providing the maximum number of patients remains
≤93 patients across the study.
The anticipated accrual rate during the dose escalation phase is estimated at 2 patients per
month. Accrual in the expansion phase is estimated at 4 patients per month across 2 centres.
It is expected that the trial will have a duration of recruitment of 12 to 24 months.
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