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Dalpiciclib Combined With Letrozole in HR+/HER2 - Gynecologic Solid Tumors

NCT06243185 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-06

No results posted yet for this study

Summary

This is a prospective, single-arm, single-center registry study to investigate 6-month progression-free survival with Dalpiciclib, a CDK4/6 kinase inhibitor, plus letrozole in patients with unresectable refractory or resistant recurrent HR-positive, HER2-negative gynecologic solid tumors." Dalpiciclib is a CDK4/6 kinase inhibitor that selectively inhibits the activity of CDK4/6 kinase, so that the complex with Cyclin D cannot phosphorylate the downstream Rb protein and prevent cells from entering the S phase from G1 phase, thereby inhibiting cell proliferation and anti-tumor effects.

Conditions

  • Recurrent Ovarian Carcinoma

Interventions

DRUG

Dalpiciclib plus letrozole

Dalpiciclib 150mg qd, d1-21, repeated once every 4 weeks. Letrozole 2.5mg qd, repeated once every 4 weeks.

Sponsors & Collaborators

  • Fengzhi Feng

    lead OTHER

Principal Investigators

  • Zhi f Feng, PhD · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-17
Primary Completion
2024-12-31
Completion
2025-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06243185 on ClinicalTrials.gov