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RECRUITING
NCT07815522
PHASE2

Abiraterone With Dalpiciclib in Salivary Gland Carcinoma

Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

View on ClinicalTrials.gov

Summary

This study is a single center, non controlled, prospective phase II clinical trial to evaluate the efficacy and safety of abiraterone combined with dalpiciclib in recurrent/metastatic salivary gland carcinoma patients with AR positive and Her-2 negative. The participants would receive abiraterone combined with dalpiciclib until termination criteria are met.

Official title: A Prospective, Open-Label, Single-Arm, Phase II Clinical Study of Abiraterone Combined With Dalpiciclib in Patients With HER-2-Negative, AR-Positive Recurrent/Metastatic Salivary Gland Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-10-01

Completion Date

2029-10-01

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

DRUG

abiraterone combined with dalpiciclib

The dosing regimen for abiraterone combined with dalpiciclib isethionate is as follows: abiraterone is administered orally at 1 g once daily, in combination with prednisone 5 mg orally twice daily. The recommended dose of dalpiciclib isethionate is 150 mg once daily for 21 consecutive days, followed by a 7-day treatment break (3-on/1-off schedule), constituting a 28-day treatment cycle. Study subjects should take the medication at approximately the same time each day. Subjects will continue abiraterone plus dalpiciclib isethionate treatment until discontinuation criteria are met.

Locations (1)

the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China