PIPA: Combination of PI3 Kinase Inhibitors and PAlbociclib
Status:
Unknown status
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Collaborators:
Institute of Cancer Research, United Kingdom Pfizer Roche Pharma AG