Sapanisertib and Serabelisib for Endometrial Cancer

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

Recruiting Phase 2 Interventional Study
Endometrial Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Faeth Therapeutics · Industry
Who this trial is looking for

This trial is looking for women with advanced or recurring endometrial cancer. Participants will receive a combination of sapanisertib, serabelisib, and paclitaxel. They must have had some previous treatments for their cancer.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with endometrioid endometrial carcinoma.
  • I have advanced or recurrent endometrial cancer that cannot be treated with surgery or radiation.
  • I have received at least 1 but no more than 4 prior treatments for my cancer.
  • I have a specific gene alteration related to cancer growth.
  • I have at least one measurable tumor.
  • I am a non-pregnant, non-lactating woman and I am postmenopausal or surgically sterile.
  • My performance status is 1 or lower.

You may not be able to join if

  • I have central nervous system metastases that haven't been treated.
  • I have another active cancer within the past 24 months.
  • I have gastrointestinal issues that could affect treatment absorption.
  • I have significant bleeding from my cancer or other sources.
  • I have serious heart problems.
  • I have an active infection that requires treatment.
  • I am taking part in another clinical trial.
  • I have had radiation therapy in the last 21 days.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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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 4 prior systemic t…
Contacts

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