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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Serabelisib is a selective, small molecule inhibitor of PI3Kα.
Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine/threonine kinase.
Fulvestrant is a first-in-class SERD.
START Los Angeles
Los Angeles, California, United States
RECRUITINGOncology Associates of Oregon
Springfield, Oregon, United States
RECRUITINGSCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGSafety 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
Objective Response Rate (ORR)
Defined as the proportion of participants from the Response-Evaluable population who have confirmed best overall response of either CR or PR according to RECIST v1.1 as confirmed by the Investigator.
Time frame: Up to 2 years.
Progression Free Survival (PFS)
Defined as the time from first dose to the date of the first evidence of disease progression or death.
Time frame: Up to 5 years.
Progression Free Survival (PFS) at 6 months
Defined as the progression free survival (PFS) rate at 6 months.
Time frame: 6 months
Overall Survival (OS)
Defined as the time from first dose to the date of death due to any cause.
Time frame: Up to 5 years.
Clinical Benefit Rate (CBR)
Defined as the percentage of participants from the All Treated population who achieve CR, PR, or SD.
Time frame: Up to 5 years.
Duration of Response (DoR)
Defined for participants with a confirmed CR or PR as the time from response to the date of first evidence of disease progression or death.
Time frame: Up to 5 years.
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