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RECRUITING Phase 2

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

NCT06463028 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Paclitaxel
  • DRUG Sapanisertib
  • DRUG Serabelisib

Study Locations (18)

Florida

  • Mount Sinai Comprehensive Cancer Center — Miami Beach
  • Florida Cancer Specialists, North — St. Petersburg
  • Florida Cancer Specialists, East — West Palm Beach

California

  • UC San Diego Moores Cancer Center — La Jolla
  • University of California, San Francisco (UCSF) — San Francisco

New York

  • Women's Cancer Care Associates, LLC — Albany
  • Memorial Sloan Kettering Cancer Center — New York

Oregon

  • Oncology Associates of Oregon, P.C. — Eugene
  • Northwest Cancer Specialists, P.C. — Portland

Pennsylvania

  • Alliance Cancer Specialists, PC — Doylestown
  • West Penn Hospital — Pittsburgh

Texas

  • Texas Oncology - West Texas — El Paso
  • Texas Oncology - Gulf Coast — The Woodlands

Maryland

  • Maryland Oncology Hematology, P.A. — Brandywine

Minnesota

  • Minnesota Oncology Hematology, P.A. — Maple Grove

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-12-12
Est. Completion 2029-09
Phase Phase 2

Sponsor

Faeth Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06463028

The ClinicalTrials.gov registry entry for NCT06463028 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Faeth Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Endometrial Cancer appearing as the primary indexed condition, and to 3 interventions — of which Paclitaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06463028 reports 18 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06463028 about?

NCT06463028 is a clinical study titled "Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer". 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.

What is the current status of trial NCT06463028?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2024-12-12. Estimated completion is 2029-09.

What conditions does trial NCT06463028 study?

This clinical trial studies the following conditions: Endometrial Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06463028?

The interventions under investigation include: Paclitaxel (DRUG), Sapanisertib (DRUG), Serabelisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06463028?

This trial is sponsored by Faeth Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06463028 being conducted?

This trial has 18 study locations across California, Florida, Maryland, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial