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

ConditionEndometrial Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKartos Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Navtemadlin

    Drug

    Navtemadlin is an experimental MDM2 anticancer drug taken by mouth

  • Navtemadlin Placebo

    Drug

    Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth

Treatment groups

268 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Part 1 Arm 1Experimental treatment 1 intervention
Group B: Part 1 Arm 2Experimental treatment 1 intervention
Group C: Part 1 Arm 3No intervention 0 interventions
Group D: Part 2 Arm AExperimental treatment 1 intervention
Group E: Part 2 Arm BExperimental treatment 1 intervention
Group F: Part 2 Arm CPlacebo comparator 1 intervention
Group G: Part 2 Arm DPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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 outcomes

1

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
2

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
3

Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin

Will determine the Maximum observed concentration (Cmax)

Time frame
1 day
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kartos Therapeutics, Inc.

Lead sponsor

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

GOG Foundation

Collaborator

Source ClinicalTrials.gov
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