This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer.
This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer who have failed prior systemic therapies, including a platinum-based therapy and an immune checkpoint inhibitor, either separately or together.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
UC San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGObjective Response Rate (ORR)
Defined as the proportion of participants with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR).
Time frame: Up to 2 years
Progression free survival (PFS)
Defined as the time from first dose until the date of disease progression or death.
Time frame: Up to 5 years.
Progression free survival (PFS) at 6 months
Defined as PFS rate at 6 months.
Time frame: Up to 5 years.
Overall survival (OS)
Defined as the time from first dose to death.
Time frame: Up to 5 years.
Clinical benefit rate (CBR)
Defined as the percentage of participants who achieve complete response (CR), partial response (PR), or have stable disease (SD) of at least 16 or 24 weeks.
Time frame: Up to 5 years.
Duration of response (DoR)
Defined for participants with confirmed CR or PR as the time from response until date of documented disease progression or death.
Time frame: Up to 5 years.
Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs)
Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0).
Time frame: Up to 2 years.
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University of California, San Francisco (UCSF)
San Francisco, California, United States
RECRUITINGMount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
RECRUITINGFlorida Cancer Specialists, North
St. Petersburg, Florida, United States
RECRUITINGFlorida Cancer Specialists, East
West Palm Beach, Florida, United States
RECRUITINGMaryland Oncology Hematology, P.A.
Brandywine, Maryland, United States
RECRUITINGMinnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, United States
RECRUITINGWomen's Cancer Care Associates, LLC
Albany, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGUniversity of Cincinnati Medical Center
Cincinnati, Ohio, United States
RECRUITING...and 8 more locations