Navtemadlin as Maintenance Treatment for Endometrial Cancer After Chemotherapy
Tests navtemadlin maintenance therapy in adults with advanced or recurrent endometrial cancer.
Plain-language title generated from the registry record
Registry title: Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
Key facts
- Where
- Haifa, Jerusalem, and Tel Aviv, IsraelSee the 3 sites
- Phase
- Phase 2/3
Where in Israel
- Rambam Medical CenterHaifa, IsraelTaking people
- Shaare Zedek Medical CenterJerusalem, IsraelTaking people
- Sourasky Medical CenterTel Aviv, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kartos Therapeutics, Inc.
- Trial code
- NCT05797831
- Record updated
- 2 May 2024
- Original description
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.Read full original descriptionShow less
A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy
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.
Inclusion: 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: Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days); Indwelling surgical drains; History of major organ transplant; History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks); Grade 2 or higher QTc prolongation; Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation.