Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced or Metastatic Breast Cancer
Summary
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.
Detailed description
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.
Arms & interventions
- DrugSerabelisib
Serabelisib is a selective, small molecule inhibitor of PI3Kα.
- DrugSapanisertib
Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine/threonine kinase.
- DrugFulvestrant
Fulvestrant is a first-in-class SERD.
Outcome measures
Primary
Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs)
Graded according to the National Cancer Institute (NCI CTCAE v5.0).
Time frame: 2 years
Secondary
Objective Response Rate (ORR)
Time frame: Up to 2 years.
Progression Free Survival (PFS)
Time frame: Up to 5 years.
Progression Free Survival (PFS) at 6 months
Time frame: 6 months
Overall Survival (OS)
Time frame: Up to 5 years.
Clinical Benefit Rate (CBR)
Time frame: Up to 5 years.
Duration of Response (DoR)
Time frame: Up to 5 years.
Eligibility criteria
Study locations (3)
START Los Angeles
Los Angeles, California, 90025
Oncology Associates of Oregon
Springfield, Oregon, 97477
SCRI Oncology Partners
Nashville, Tennessee, 37203