Actively Recruiting
A Phase Ib/II Study Confirmed Inhibition of Autophagy Synergizes Anti-tumor Effect of High Dose CDK4/6i
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-12-03
29
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 administered in combination. The trial will use the first cycle (28 days) as the observation period for tolerability, observing and evaluating the occurrence of DLTs after medication and determining the maximum tolerated dose/maximum administered dose (MTD/MAD) and recommended phase 2 dose (RP2D) of the combination therapy. This study improves the efficacy of CDK4/6 inhibitors in the treatment of solid tumors by reversing DTP status through the use of HCQ.
CONDITIONS
Official Title
A Phase Ib/II Study Confirmed Inhibition of Autophagy Synergizes Anti-tumor Effect of High Dose CDK4/6i
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with advanced solid tumors confirmed by histology or cytology, including breast cancer and undifferentiated liposarcoma
- Have failed CDK4/6 inhibitor treatment or experienced failure of neoadjuvant or adjuvant CDK4/6 inhibitor therapy within 12 months
- At least one measurable target lesion per RECIST 1.1
- Age 18 years or older, any gender
- ECOG performance status of 0 to 2
- Expected survival of at least 3 months
- Baseline blood tests within one week before enrollment showing ANC 65 1.5 x 10^9/L, hemoglobin 65 9 g/dL, and platelet count 65 75 x 10^9/L without recent transfusions or growth factors
- Baseline liver and kidney function tests within normal limits or defined thresholds within one week before enrollment
- Fertile patients must agree to use reliable contraception during the trial and for at least 3 months after last dose
- Pre-menopausal women must have a negative pregnancy test before enrollment and commit to contraception during and 6 months after the study
- Male participants must commit to contraception with partners during and 6 months after the study
You will not qualify if you...
- Major visceral surgery or significant trauma within 4 weeks before the first dose (excluding needle biopsies)
- Prior radiotherapy and treatment with two or more CDK4/6 inhibitors for advanced/metastatic disease
- Unresolved adverse reactions from previous anti-tumor therapy worse than CTCAE grade 1, except manageable toxicities
- Symptomatic peripheral neuropathy grade 2 or higher from prior treatment
- Uncontrolled central nervous system or leptomeningeal metastases
- Pregnancy or breastfeeding
- Active uncontrolled infections, history of immune deficiency, positive HIV, active hepatitis B or C (unless controlled)
- Severe cardiovascular or cerebrovascular conditions, including serious arrhythmias, QTcF > 470 ms, recent major cardiac events, or uncontrolled hypertension
- Psychiatric disorders or poor compliance
- Retinal vascular disease making hydroxychloroquine use unsafe
- Other medical conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
T
Tao Qin, Phd
CONTACT
C
Chang Gong, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here