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Study of Narazaciclib (ON 123300) Plus Letrozole in Endometrial Cancer and Other Gynecologic Malignancies

NCT05705505 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-12-12

No results posted yet for this study

Summary

This study will assess the safety and efficacy of increasing doses of narazaciclib (ON 123300) in combination with the standard daily dose (2.5mg) of letrozole in patients with Recurrent Metastatic Low-grade Endometrioid Endometrial Cancer and other Gynecologic Malignancies.

Conditions

  • Endometrioid Endometrial Cancer

Interventions

DRUG

Narazaciclib

Orange tablets, each containing 40 mg or 120 mg of narazaciclib as narazaciclib monolactate

DRUG

Letrozole 2.5mg

Tablet

Sponsors & Collaborators

  • Traws Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Victor Moyo, MD · Onconova Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2026-01-31
Completion
2026-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05705505 on ClinicalTrials.gov