RecruitingInterventionalPhase 2/Phase 3

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

NCT ID: NCT05797831Sponsor: Kartos Therapeutics, Inc.Last updated: 2024-05-02

Summary

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.

Arms & interventions

DrugNavtemadlin
Navtemadlin is an experimental MDM2 anticancer drug taken by mouth
DrugNavtemadlin Placebo
Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth

Outcome measures

Primary

Part 1: To determine the navtemadlin Phase 3 dose
Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1
Time frame: 12 months
Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo
PFS defined as the time from randomization to disease progression by IRC or death, whichever occurs first
Time frame: 50 months

Secondary

Part 1: To evaluate the treatment effect of navtemadlin on PFS by IRC and investigator assessment
Time frame: 50 months
Part 2: To evaluate the treatment effect of navtemadlin on the time to first subsequent treatment (TFST)
Time frame: 50 months
Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin
Time frame: 1 day
Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin
Time frame: 1 day
Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin
Time frame: 1 day
Parts 1 and 2: To evaluate the treatment effect of navtemadlin on the disease control rate (DCR)
Time frame: 50 months

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No

Inclusion 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) Exclusion Criteria: * 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)

Study locations (19)

Kaiser Permanente Center

Vallejo, California, 94589

Recruiting

Northside Hospital

Atlanta, Georgia, 30342

Recruiting

St. Joseph

Savannah, Georgia, 31405

Recruiting

Dr. Sudarshan K. Sharma, Ltd.

Hinsdale, Illinois, 60521

Recruiting

Parkview Research Center

Fort Wayne, Indiana, 46845

Recruiting

Indiana University

Indianapolis, Indiana, 46202

Recruiting

Maryland Oncology Hematology, P.A.

Silver Spring, Maryland, 20904

Recruiting

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, 55404

Recruiting

Washington University School of Medicine

St Louis, Missouri, 63108

Recruiting

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89106

Recruiting

Good Samaritan Hospital Medical Center

West Islip, New York, 11795

Recruiting

FirstHealth Carolinas

Pinehurst, North Carolina, 28374

Recruiting

OhioHealth Institute

Columbus, Ohio, 43214

Recruiting

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, 74146

Recruiting

Oncology Associates of Oregon

Eugene, Oregon, 97401

Recruiting

Northwest Cancer Specialists

Portland, Oregon, 97227

Recruiting

Texas Oncology-Austin Central

Austin, Texas, 78745

Recruiting

Texas Oncology-Fort Worth Cancer Center

Fort Worth, Texas, 76104

Recruiting

Texas Oncology-San Antonio Medical Center

San Antonio, Texas, 78130

Recruiting