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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
268
Navtemadlin is an experimental MDM2 anticancer drug taken by mouth
Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth
Kaiser Permanente Center
Vallejo, California, United States
RECRUITINGNorthside Hospital
Atlanta, Georgia, United States
RECRUITINGSt. Joseph
Savannah, Georgia, United States
RECRUITINGDr. Sudarshan K. Sharma, Ltd.
Hinsdale, Illinois, United States
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
Part 1: To evaluate the treatment effect of navtemadlin on PFS by IRC and investigator assessment
PFS defined as the time from randomization to disease progression by IRC/investigator assessment or death, whichever occurs first
Time frame: 50 months
Part 2: To evaluate the treatment effect of navtemadlin on the time to first subsequent treatment (TFST)
TFST defined as the time from randomization to initiation of first subsequent anticancer therapy or death, whichever occurs first
Time frame: 50 months
Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin
Will determine the Maximum observed concentration (Cmax)
Time frame: 1 day
Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin
Will determine the area under the plasma concentration versus time curve (AUC)
Time frame: 1 day
Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin
Will determine the time of maximum plasma concentration (Tmax)
Time frame: 1 day
Parts 1 and 2: To evaluate the treatment effect of navtemadlin on the disease control rate (DCR)
Best response of complete response (CR), partial response (PR) or stable disease (SD) by IRC/investigator assessment among subjects with PR as best response from prior chemotherapy
Time frame: 50 months
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Parkview Research Center
Fort Wayne, Indiana, United States
RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITINGMaryland Oncology Hematology, P.A.
Silver Spring, Maryland, United States
RECRUITINGMinnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGWomen's Cancer Center of Nevada
Las Vegas, Nevada, United States
RECRUITING...and 73 more locations