NCT05953350View on ClinicalTrials.gov

A Phase Ib/II Study Confirmed Inhibition of Autophagy Synergizes Anti-tumor Effect of High Dose CDK4/6i

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

November 7, 2023

Primary Completion Date

May 7, 2024

Study Completion Date

December 31, 2024

Conditions
Inhibition of Autophagy Synergizes Anti-tumor Effect
Interventions
DRUG

600mg bid dose of hydroxychloroquine combined with three predefined dose groups of palbociclib

hydroxychloroquine group of 600mg bid combined with three predefined dose groups of palbociclib: 100mg QD, 150mg QD, and 200mg QD, separately.

DRUG

RP2D dose of 600mg bid of hydroxychloroquine combined with palbociclib was selected for phase II clinical trial.

After the exploration of 600mg bid dose of hydroxychloroquine combined with palbociclib, and the maximal tolerated dose (MTD) was determined, then RP2D dose of 600mg bid dose of hydroxychloroquine combined with palbociclib was selected for phase II clinical trial.

Trial Locations (1)

510120

RECRUITING

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou

All Listed Sponsors
lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER