What side effects are associated with this type of intervention?

Common treatments for endometrial cancer, such as chemotherapy with agents like carboplatin and paclitaxel, often cause side effects including fatigue, nausea, vomiting, hair loss, and increased risk of infection. Radiation therapy can lead to skin irritation, fatigue, and gastrointestinal issues. MDM2 inhibitors like Navtemadlin, being studied for endometrial cancer, may cause side effects such as nausea, fatigue, and hematologic toxicities like thrombocytopenia and neutropenia.

What prior FDA approvals exist?

The FDA has approved several treatments for endometrial cancer, including hormonal therapies, chemotherapy, and targeted therapies. While the context does not provide specific details on MDM2 inhibitors like Navtemadlin, it does mention the use of molecular profiling and precision cancer medicine as emerging approaches. Traditional treatments include drugs like everolimus combined with exemestane, which are used based on molecular characteristics of the tumor. For advanced or recurrent cases, participation in clinical trials exploring novel agents, such as Navtemadlin, is encouraged to potentially improve outcomes.

What other types of research exist?

Promising novel alternatives to Navtemadlin for endometrial cancer patients include: 1) Lenvatinib plus Pembrolizumab, which has shown superiority in progression-free survival and overall survival in a phase 3 trial (KEYNOTE-775). 2) Temsirolimus, an mTOR inhibitor, especially when combined with Bevacizumab, which showed a response rate of 25% in a trial. 3) Everolimus combined with Letrozole, which demonstrated a clinical benefit rate of 40% in a phase II study. These alternatives have shown potential in clinical trials and may be considered for treatment in 2024.

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Navtemadlin for Endometrial Cancer

Phase 2 & 3

Recruiting

Research Sponsored by Kartos Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 50 months

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of navtemadlin are not listed here, common ones may include fatigue, nausea, risk of infection due to low blood counts from bone marrow suppression; liver or kidney issues could also be monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 50 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~50 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 50 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: To determine the navtemadlin Phase 3 dose

Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo

Secondary study objectives

Part 1: To evaluate the treatment effect of navtemadlin on PFS by IRC and investigator assessment

Part 2: To evaluate the treatment effect of navtemadlin on the time to first subsequent treatment (TFST)

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

+1 more

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Part 2 Arm BExperimental Treatment1 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 AExperimental Treatment1 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 2Experimental Treatment1 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 1Experimental Treatment1 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 3Active Control1 Intervention

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

Group VI: Part 2 Arm DPlacebo Group1 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 CPlacebo Group1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endometrial cancer include chemotherapy, hormonal therapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cells, while hormonal therapy targets hormone receptors to slow cancer growth. Targeted therapies, such as MDM2 inhibitors like Navtemadlin, block specific proteins involved in cancer cell survival. MDM2 inhibitors restore the function of the tumor suppressor p53, leading to increased cancer cell death. This targeted approach is significant for endometrial cancer patients as it may improve treatment efficacy and reduce side effects compared to traditional therapies.

Identification of a Novel Epithelial-Mesenchymal Transition-Related Gene Signature for Endometrial Carcinoma Prognosis.