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.
Histologically confirmed diagnosis of endometrioid endometrial carcinoma.
Documented evidence of advanced or recurrent endometrial cancer that is not amenable to surgery/radiation for curative intent.
Participant has received at least 1 but not more than 4 prior systemic therapies. Prior therapy must include platinum-based chemotherapy and a checkpoint inhibitor, either separately or in combination. If a subject has been unable to be treated with checkpoint inhibitor in the past due to medical contraindications, consult with Medical Monitor.
PI3K/AKT/mTOR pathway gene alteration identified.
Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study
Active malignancy (except for endometrial cancer, definitively treated in-situ carcinomas [e.g., breast, cervix, bladder], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible.
Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.
Clinically significant (per Investigator judgement) hemoptysis or tumor bleeding.
Single group
Sapanisertib
DrugOral
Serabelisib
DrugOral
Paclitaxel
DrugInfusion
Objective Response Rate (ORR)
Defined as the proportion of participants with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR).
Progression free survival (PFS)
Defined as the time from first dose until the date of disease progression or death.
Progression free survival (PFS) at 6 months
Defined as PFS rate at 6 months.
Overall survival (OS)
Defined as the time from first dose to death.
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.
Click on the lead sponsor to view all of their trials.
Faeth Therapeutics
Lead sponsor
GOG Foundation
Collaborator
