Endometrial Cancer
Conditions
Keywords
navtemadlin
Brief 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.
Interventions
DRUGNavtemadlin
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
Sponsors
European Network of Gynaecological Oncological Trial Groups (ENGOT)
GOG Foundation
Kartos Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: To determine the navtemadlin Phase 3 dose | 12 months | Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1 |
| Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo | 50 months | PFS defined as the time from randomization to disease progression by IRC or death, whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: To evaluate the treatment effect of navtemadlin on PFS by IRC and investigator assessment | 50 months | PFS defined as the time from randomization to disease progression by IRC/investigator assessment or death, whichever occurs first |
| Part 2: To evaluate the treatment effect of navtemadlin on the time to first subsequent treatment (TFST) | 50 months | TFST defined as the time from randomization to initiation of first subsequent anticancer therapy or death, whichever occurs first |
| Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin | 1 day | Will determine the Maximum observed concentration (Cmax) |
| Parts 1 and 2: To evaluate the treatment effect of navtemadlin on the disease control rate (DCR) | 50 months | 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 |
Countries
Austria, Canada, Denmark, Estonia, Finland, Georgia, Hungary, Israel, Italy, Lithuania, Norway, Poland, Romania, Slovenia, Spain, Sweden, United States
Contacts
Primary ContactJohn Mei
Outcome results
None listed