What side effects are associated with this type of intervention?

Common treatments for endometrial cancer include CDK inhibitors like Narazaciclib and aromatase inhibitors like Letrozole. CDK inhibitors can cause side effects such as neutropenia, fatigue, nausea, and diarrhea. Aromatase inhibitors, on the other hand, are associated with side effects like joint pain, hot flashes, osteoporosis, and an increased risk of cardiovascular events. Both treatments aim to manage cancer growth but come with their respective adverse effects that need to be monitored.

What prior FDA approvals exist?

The FDA has approved several treatments for endometrial cancer, particularly focusing on hormone receptor-positive cases. Aromatase inhibitors like Letrozole are used to reduce estrogen levels, which can help slow the growth of hormone-sensitive tumors. While specific CDK inhibitors for endometrial cancer are still under investigation, similar drugs have been approved for other hormone receptor-positive cancers, such as breast cancer. These include Palbociclib, Ribociclib, and Abemaciclib, which inhibit cyclin-dependent kinases (CDKs) to prevent cancer cell proliferation. The combination of these types of drugs aims to provide a more targeted approach to treatment.

What other types of research exist?

Promising novel alternatives for Endometrial Cancer treatment in 2024 include: <ol> <li>Pembrolizumab (an immune checkpoint inhibitor) combined with Lenvatinib (a tyrosine kinase inhibitor), which has shown efficacy in advanced endometrial cancer.</li> <li></li> </ol> Dostarlimab (another immune checkpoint inhibitor) for patients with mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumors. 3. Combination therapies involving targeted agents like Everolimus (mTOR inhibitor) and Letrozole for hormone receptor-positive cases. 4. Investigational agents such as Selinexor (a selective inhibitor of nuclear export) in combination with other therapies.

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Aromatase Inhibitor

Narazaciclib + Letrozole for Endometrial Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Traws Pharma, 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 from time of first dose until 2 years after end of treatment (up to approximately 3 years).

Awards & highlights

No Placebo-Only Group

Summary

This trial tests narazaciclib with letrozole in patients with recurring and spreading gynecologic cancers. It aims to find the safest and most effective dose of narazaciclib. The combination works by directly attacking cancer cells and reducing hormone levels that help these cells grow.

Who is the study for?

This trial is for adults with recurrent metastatic low-grade endometrioid endometrial cancer who can swallow pills, have had up to two prior systemic treatments (excluding certain therapies), and whose major organs function well. They must not be pregnant, agree to use contraception if applicable, and have a life expectancy of at least 12 weeks.

What is being tested?

The study tests increasing doses of narazaciclib combined with a standard dose of letrozole in patients with specific gynecologic cancers. It aims to determine the safety and effectiveness of this combination treatment.

What are the potential side effects?

Potential side effects may include typical reactions from oral cancer medications such as nausea, fatigue, blood count changes, liver enzyme alterations, or hormonal imbalances. Specific side effects for narazaciclib are not listed but would be monitored closely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of first dose until 2 years after end of treatment (up to approximately 3 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of first dose until 2 years after end of treatment (up to approximately 3 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of first dose until 2 years after end of treatment (up to approximately 3 years). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose limiting toxicities (DLTs) will be tabulated and summarized by cohort

Phase 2 - Progression-free survival (PFS) at 24 weeks by Investigator assessment

Treatment-emergent adverse events (TEAEs), including DLTs will be graded by CTCAE v5.0

Secondary study objectives

Complete response (CR) rate

Disease control rate (DCR equals CR+PR+SD)

Duration of response (DoR)

+7 more

Other study objectives

Measurement of tyrosine kinase activity (TKa) levels in serum

PK: Area under the concentration-time curve (AUC) from time 0 to time of last quantifiable sample (AUC0-t)

PK: Time to reach Cmax (Tmax)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Escalating daily doses of narazaciclib in combination with letrozole (2.5mg day)Experimental Treatment2 Interventions

Phase 1: Initiating at 160mg per day of narazaciclib, patients will receive escalating doses of narazaciclib (oral tablets/once daily) in combination with 2.5mg of letrozole (oral tablet/once daily). Phase 2: All patients will receive the recommended phase 2 dose (RP2D) of the combination of narazaciclib (oral tablets) and letrozole (oral tablet/QD)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Letrozole 2.5mg

2019

Completed Phase 4

~1490

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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

CDK inhibitors, like Narazaciclib, work by inhibiting cyclin-dependent kinases, essential for cell cycle progression, thereby halting cancer cell proliferation. Aromatase inhibitors, such as Letrozole, reduce estrogen levels by inhibiting the enzyme aromatase, slowing the growth of hormone receptor-positive endometrial cancer cells. These mechanisms are crucial for patients to understand as they highlight how these treatments specifically target cancer growth and proliferation, potentially leading to more effective disease management.

Systemic therapy for endometrial stromal sarcomas: current treatment options.