Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

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.

Official Title

An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, and a Substudy Evaluating PIKTOR With Paclitaxel Plus Diet, in Patients With Advanced or Recurrent Endometrial Cancer

Details

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.

Keywords

Endometrial Cancer, 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, 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

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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..

You CAN'T join if...

  • 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.

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92037 United States
  • Oncology Associates of Oregon, P.C. accepting new patients
    Eugene Oregon 97401 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Faeth Therapeutics
Links
Related Info
ID
NCT06463028
Phase
Phase 2 Endometrial Cancer Research Study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated