Study of Narazaciclib and Letrozole for Endometrial and Other Gynecologic Cancers

Sponsor: Traws Pharma, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05705505

Provider View

This clinical trial is testing the safety and effectiveness of a new drug combination, Narazaciclib and Letrozole, in treating patients with recurrent or advanced endometrial cancer and other gynecologic cancers.

Patient Parameters

Program Overview

The study aims to find out if Narazaciclib, when combined with Letrozole, is safe and effective for patients with recurrent or advanced low-grade endometrial cancer and other gynecologic cancers. The trial will test different doses of Narazaciclib to determine the best dose to use with Letrozole.

Description

This study is divided into two phases. In Phase 1, researchers will test increasing doses of Narazaciclib combined with a standard dose of Letrozole to find the safest and most effective dose. Patients will take Narazaciclib starting at 160 mg daily, with doses increasing by 40 mg each time, along with Letrozole 2.5 mg daily, in 28-day cycles. The goal is to find the maximum dose that patients can tolerate and the minimum dose that is effective. In Phase 2a, the best dose found in Phase 1 will be given to about 30 patients with recurrent or advanced low-grade endometrial cancer. Treatment will continue until the cancer progresses, the patient chooses to stop, or side effects become too severe.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • For Phase 1: Have confirmed endometrial or other gynecologic cancer suitable for hormone therapy and no other standard treatment options.
  • For Phase 2a: Have confirmed low-grade endometrial cancer.
  • Have recurrent or advanced cancer.
  • For Phase 1: May have had any number of previous treatments.
  • For Phase 2a: Have had 1 or 2 previous treatments for advanced cancer.
  • Have measurable cancer outside of any previously treated areas.
  • Have results from specific cancer tests available.
  • Be in good overall health with a performance status of 0 or 1.
  • Have adequate organ function based on specific blood tests.
  • Be able to swallow pills.
  • Have a life expectancy of at least 12 weeks.
  • Women must be postmenopausal or use effective birth control during the study.

Exclusion Criteria

  • For Phase 1: Cancer other than endometrial or other gynecologic cancer.
  • For Phase 2a: Non-low-grade endometrial cancer or other specific types of cancer.
  • Have taken a CDK 4/6 inhibitor before.
  • Have significant medical or psychiatric conditions that could interfere with the study.
  • Have a heart condition that increases the risk of a specific heart rhythm problem.
  • Have uncontrolled medical conditions or infections.
  • Are taking certain medications that affect liver enzymes.
  • Have had recent blood clots or are at high risk for them.
  • Have severe diarrhea or high calcium levels.
  • Are pregnant or breastfeeding.
  • Have had major surgery recently.
  • Have received a live vaccine recently.
  • Have active infections, including HIV, hepatitis, or COVID-19.
  • Have had another cancer in the past 2 years, except for certain skin or cervical cancers.
  • Have significant heart or lung conditions.
  • Are not candidates for Letrozole treatment.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.