Navtemadlin for Endometrial Cancer

Recruiting at 82 trial locations

Overseen By John Mei

Age: 18+

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Kartos Therapeutics, Inc.

Disqualifiers: Sarcomas, Small-cell carcinomas, Organ transplant, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

268 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests navtemadlin to see if it can prevent endometrial cancer from returning in patients who responded well to chemotherapy. The study will check the safety and effectiveness of different doses of the drug.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for patients with advanced or recurrent endometrial cancer who responded well to a specific chemo. They must have normal TP53 genes, good performance status (ECOG 0-1), and proper blood, liver, and kidney function. It's not for those with recent major bleeding, organ transplants, certain other cancers, recent experimental therapies or immune/cytokine therapy.

Inclusion Criteria

I am fully active or can carry out light work.

My endometrial cancer is confirmed and does not have TP53 mutations.

I completed a specific chemotherapy and my cancer responded well.

Exclusion Criteria

I haven't had major bleeding or brain bleeding in the last 6 months.

I currently have surgical drains in place.

My cancer is a type of sarcoma or has small-cell features with neuroendocrine traits.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Evaluation of safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose

12 months

Monthly visits for safety and efficacy assessment

Treatment Part 2

Evaluation of the efficacy and safety of navtemadlin Phase 3 dose compared to placebo

50 months

Monthly visits for progression-free survival assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Navtemadlin
• Navtemadlin Placebo

Trial Overview The study tests navtemadlin as a maintenance treatment after chemotherapy success in two parts: first to find the best dose comparing two levels of navtemadlin against observation; second to compare that dose's effectiveness and safety against a placebo.

Participant Groups

Group I: Part 2 Arm B Experimental Treatment 1 Intervention

Navtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.

Group II: Part 2 Arm A Experimental Treatment 1 Intervention

Navtemadlin administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.

Group III: Part 1 Arm 2 Experimental Treatment 1 Intervention

Navtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.

Group IV: Part 1 Arm 1 Experimental Treatment 1 Intervention

Navtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.

Group V: Part 1 Arm 3 Active Control 1 Intervention

Observational control ("watch and wait") on a 28-day cycle.

Group VI: Part 2 Arm D Placebo Group 1 Intervention

Placebo administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.

Group VII: Part 2 Arm C Placebo Group 1 Intervention

Placebo administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.

Who Is Running the Clinical Trial?

Kartos Therapeutics, Inc.

Lead Sponsor

Trials

17

Recruited

2,100+

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Trials

41

Recruited

19,200+

GOG Foundation

Collaborator

Trials

48

Recruited

18,500+