Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With Diet in Patients With Advanced/Recurrent Endometrial Cancer

Trial Title: Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With Diet in Patients With Advanced/Recurrent Endometrial Cancer

NCT ID: NCT06463028

Condition: Endometrial Cancer

Conditions: Official terms:
Endometrial Neoplasms
Paclitaxel
Serabelisib

Conditions: Keywords:
Serabelisib
Sapanisertib
Paclitaxel
Taxol
Antineoplastic Agents
PI3K
AKT
mTOR
Dual PI3K/mTOR inhibition
Genetic mutation
Cisplatin
Carboplatin
Genital Diseases
Endometrial Neoplasms
Advanced Endometrial Carcinoma
Recurrent Endometrial Carcinoma
Metastatic Endometrial Carcinoma
Endometrial Cancer
Endometrioid Carcinoma
Cancer of Endometrium
Cancer of the Endometrium
Carcinoma of Endometrium
Endometrial Carcinoma
Endometrium Cancer
Neoplasms, Endometrial
Metabolism
Synthetic Lethality
Metabolism Programming
PIK3CA
PIK3CA Mutation
PI3K Gene Mutation
PI3K/AKT/mTOR Pathway Mutation
AKT Gene Mutation
mTOR Gene Mutation

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Sapanisertib
Description: Oral
Arm group label: sapanisertib and serabelisib (PIKTOR) with paclitaxel

Other name: FTH-003

Other name: MLN0128

Intervention type: Drug
Intervention name: Serabelisib
Description: Oral
Arm group label: sapanisertib and serabelisib (PIKTOR) with paclitaxel

Other name: FTH-001

Other name: MLN1117

Intervention type: Drug
Intervention name: Paclitaxel
Description: Infusion
Arm group label: sapanisertib and serabelisib (PIKTOR) with paclitaxel

Summary: 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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 3 prior systemic therapies. Prior therapy must include platinum-based chemotherapy and a checkpoint inhibitor, either separately or in combination. - PI3K/AKT/mTOR pathway gene alteration identified. - At least 1 measurable target lesion according to RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening. - Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods.. Exclusion Criteria: - 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. - Gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment. - Clinically significant hemoptysis or tumor bleeding. - Significant cardiovascular impairment. - Active, uncontrolled (requiring systemic antimicrobial therapy) infection. - Concurrent participation in another therapeutic clinical trial. - Prior radiation therapy within 21 days prior to start of study treatment. - Strong CYP3A4 inhibitors, strong CYP1A2 inhibitors or CYP1A2 inducers, or clinically significant CYP3A4 inducers within 7 days before the first dose of study intervention, or participants who require treatment with strong CYP3A4 inhibitors or inducers during the study. - Participants who require PPIs or chronic use of antacids, histamine H2 receptor blockers, or other treatments to raise gastric pH. - Prolongation of QTc interval to >480 ms. - HbA1c ≥ 8.0%, fasting serum glucose > 160 mg/dL, fasting triglycerides > 300 mg/dL or receiving treatment with insulin.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: December 31, 2024

Completion date: September 2029

Lead sponsor:
Agency: Faeth Therapeutics
Agency class: Industry

Collaborator:
Agency: GOG Foundation
Agency class: Other

Source: Faeth Therapeutics

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06463028
https://faeththerapeutics.com/