Abiraterone With Dalpiciclib in Salivary Gland Carcinoma
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
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
36 participants
Oct 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
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)
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NCT07815522