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New treatment option for Endometrial Cancer
Official title Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer
ClinicalTrials.gov ID: NCT06463028
What this study is testing
What is Sapanisertib?
Sapanisertib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for endometrial cancer.
Also referred to as FTH-003, MLN0128.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- PI3K/AKT/mTOR pathway gene alteration identified.
- At least 1 measurable target lesion according to RECIST v1.1
You likely 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...
- Active malignancy (except for endometrial cancer, definitively treated in-situ carcinomas [e.g., breast, cervix, bladder], or basal or squamous cell...
- Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that...
- Clinically significant (per Investigator judgement) hemoptysis or tumor bleeding.
- Significant cardiovascular impairment.
- Active, uncontrolled (requiring systemic antimicrobial therapy) infection.
See the full eligibility 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 4 prior systemic therapies. Prior therapy must include platinum-based chemotherapy and a checkpoint inhibitor, either separately or in combination. If a subject has...
- 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..
- 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...
- 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...
- 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.
- 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 and inducers are prohibited during the study. Strong CYP1A2 inhibitors as well as CYP1A2 inducers should be administered with caution and at the discretion of the Investigator. Alternative...
- 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% or fasting serum glucose \> 160 mg/dL or fasting triglycerides \> 300 mg/dL or receiving treatment with insulin.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- San Francisco, California, United States
- Miami Beach, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Brandywine, Maryland, United States
- Maple Grove, Minnesota, United States
- Albany, New York, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Eugene, Oregon, United States
- Portland, Oregon, United States
- Doylestown, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
- El Paso, Texas, United States
- The Woodlands, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; San Francisco, California, United States; Miami Beach, Florida, United States; St. Petersburg, Florida, United States; West Palm Beach, Florida, United States; Brandywine, Maryland, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.