Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer

Description

This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.

Conditions

Endometrial Cancer

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Study Overview

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Study Details

Study overview

This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.

A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy

Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer

Condition
Endometrial Cancer
Intervention / Treatment

-

Contacts and Locations

Vallejo

Kaiser Permanente Center, Vallejo, California, United States, 94589

Atlanta

Northside Hospital, Atlanta, Georgia, United States, 30342

Savannah

St. Joseph, Savannah, Georgia, United States, 31405

Hinsdale

Dr. Sudarshan K. Sharma, Ltd., Hinsdale, Illinois, United States, 60521

Fort Wayne

Parkview Research Center, Fort Wayne, Indiana, United States, 46845

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Silver Spring

Maryland Oncology Hematology, P.A., Silver Spring, Maryland, United States, 20904

Minneapolis

Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota, United States, 55404

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63108

Las Vegas

Women's Cancer Center of Nevada, Las Vegas, Nevada, United States, 89106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * ECOG 0-1
  • * Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT
  • * Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1
  • * Adequate hematologic, hepatic and renal function (within 14 days)
  • * Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation
  • * Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days)
  • * Indwelling surgical drains
  • * Grade 2 or higher QTc prolongation
  • * History of major organ transplant
  • * History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kartos Therapeutics, Inc.,

Study Record Dates

2027-07