Phase
Condition
Endometrial Cancer
Vaginal Cancer
Pelvic Cancer
Treatment
Paclitaxel
Sapanisertib
Serabelisib
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed diagnosis of endometrioid endometrial carcinoma.
Documented evidence of advanced or recurrent endometrial cancer that is not amenableto 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 orwho agree to use effective contraceptive methods..
Exclusion
Exclusion Criteria:
Participants with central nervous system metastases are not eligible, unless theyhave completed local therapy and have discontinued the use of corticosteroids forthis indication for at least 4 weeks before starting treatment in this study
Active malignancy (except for endometrial cancer, definitively treated in-situcarcinomas [e.g., breast, cervix, bladder], or basal or squamous cell carcinoma ofthe skin) within the past 24 months prior to treatment. Fully resected localizedmalignancies are eligible.
Gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, orany 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 clinicallysignificant CYP3A4 inducers within 7 days before the first dose of studyintervention, or participants who require treatment with strong CYP3A4 inhibitors orinducers during the study.
Participants who require PPIs or chronic use of antacids, histamine H2 receptorblockers, 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/dLor receiving treatment with insulin.
Study Design
Study Description
Connect with a study center
UC San Diego Moores Cancer Center
La Jolla, California 92037
United StatesActive - Recruiting
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
United StatesActive - Recruiting
Florida Cancer Specialists, North
Saint Petersburg, Florida 33705
United StatesActive - Recruiting
Florida Cancer Specialists, East
West Palm Beach, Florida 33401
United StatesActive - Recruiting
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota 55369
United StatesActive - Recruiting
Women's Cancer Care Associates, LLC
Albany, New York 12208
United StatesActive - Recruiting
Oncology Associates of Oregon, P.C.
Eugene, Oregon 97401
United StatesActive - Recruiting
Northwest Cancer Specialists, P.C.
Portland, Oregon 97227
United StatesActive - Recruiting
Alliance Cancer Specialists, PC
Doylestown, Pennsylvania 18901
United StatesActive - Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesActive - Recruiting
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