RECRUITING

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

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Endometrial Cancernavtemadlin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2023-07-17
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05797831

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ECOG 0-1
  2. * Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT
  3. * 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
  4. * Adequate hematologic, hepatic and renal function (within 14 days)
  1. * Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation
  2. * Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days)
  3. * Indwelling surgical drains
  4. * Grade 2 or higher QTc prolongation
  5. * History of major organ transplant
  6. * History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)

Contacts and Locations

Study Contact

John Mei
CONTACT
650-542-0136
jmei@kartosthera.com

Study Locations (Sites)

Kaiser Permanente Center
Vallejo, California, 94589
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
St. Joseph
Savannah, Georgia, 31405
United States
Dr. Sudarshan K. Sharma, Ltd.
Hinsdale, Illinois, 60521
United States
Parkview Research Center
Fort Wayne, Indiana, 46845
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, 20904
United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404
United States
Washington University School of Medicine
Saint Louis, Missouri, 63108
United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106
United States
Good Samaritan Hospital Medical Center
West Islip, New York, 11795
United States
FirstHealth Carolinas
Pinehurst, North Carolina, 28374
United States
OhioHealth Institute
Columbus, Ohio, 43214
United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, 74146
United States
Oncology Associates of Oregon
Eugene, Oregon, 97401
United States
Northwest Cancer Specialists
Portland, Oregon, 97227
United States
Texas Oncology-Austin Central
Austin, Texas, 78745
United States
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas, 76104
United States
Texas Oncology-San Antonio Medical Center
San Antonio, Texas, 78130
United States

Collaborators and Investigators

Sponsor: Kartos Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-17
Study Completion Date2027-07

Study Record Updates

Study Start Date2023-07-17
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • navtemadlin

Additional Relevant MeSH Terms

  • Endometrial Cancer