Navtemadlin for Advanced Endometrial Cancer
Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
Recruiting
Phase 2
Phase 3
Interventional Study
Endometrial Cancer
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 268 (estimated)
- Sponsor
- Kartos Therapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for patients with advanced or recurrent endometrial cancer who have had a positive response to initial chemotherapy. Participants will receive navtemadlin as ongoing treatment to see how well it works compared to a placebo.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with endometrial cancer.
- I am in good overall health (ECOG 0-1).
- I have completed chemotherapy with a satisfactory response.
- I have adequate blood and organ function.
You may not be able to join if
- I have a history of major organ transplant.
- I have had certain types of cancers like sarcomas.
- I have received any immune or investigational therapy in the last 28 days.
- I have had notable issues with bleeding or major hemorrhage recently.
- I have Grade 2 or higher QTc prolongation.
- I have indwelling surgical drains.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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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. Par…
Trial Locations
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Eligibility Criteria
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
* …
Contacts