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

Recruiting Phase 1 Phase 2 Interventional Study
Inhibition of Autophagy Synergizes Anti-tumor Effect
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
29 (estimated)
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Other
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About This Trial
In order to explore the safety and antitumor efficacy of different doses of CDK4/6 inhibitor Palbociclib in combination with the autophagy inhibitor hydroxychloroquine (HCQ) , a phase Ib/II study was conducted. This study will adopt a 3+3 design and include three predefined dose groups of palbociclib: 100mg QD, 150mg QD, and 200mg QD. Initially, 600mg bid dose of hydroxychloroquine group will be …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients diagnosed with advanced solid tumors (including breast cancer, undifferentiated liposarcoma, etc.) confirmed by histology and/or cytology, who have failed CDK4/6 inhibitor treatment or have experienced failure of neoadjuvant or adjuvant CDK4/6 inhibitor therapy for 1…
Contacts

Tao Qin, Phd

+8613570396232

qint6@mail.sysu.edu.cn

CONTACT

Chang Gong, Phd

CONTACT