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New treatment option for Inhibition of Autophagy Synergizes Anti-tumor Effect
Official title A Phase Ib/II Study Confirmed Inhibition of Autophagy Synergizes Anti-tumor Effect of High Dose CDK4/6i
ClinicalTrials.gov ID: NCT05953350
What this study is testing
What is 600mg bid dose of hydroxychloroquine combined with three predefined dose groups of palbociclib?
600mg bid dose of hydroxychloroquine combined with three predefined dose groups of palbociclib is an investigational medicine, being studied as a potential treatment for inhibition of autophagy synergizes anti-tumor effect.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients diagnosed with advanced solid tumors (including breast cancer, undifferentiated liposarcoma, etc.) confirmed by histology and/or cytology...
- At least one measurable target lesion according to RECIST 1.1.
- Age 18 years or older, any gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Expected survival of at least 3 months.
You likely can't join if
- Patients who have undergone major visceral surgery (excluding needle biopsies) or significant trauma within 4 weeks prior to the first administration...
- Prior treatment with radiotherapy and two or more CDK4/6 inhibitors for advanced or metastatic disease.
- Failure to recover from adverse reactions of previous anti-tumor therapy to CTCAE 5.0 grade ≤ 1 (except for acceptable toxicities without safety...
- Clinical symptoms of central nervous system metastases or leptomeningeal metastases, or other evidence indicating uncontrolled central nervous system...
- Pregnancy (positive pregnancy test) or lactation.
- Active infection requiring systemic antimicrobial therapy that is not under control at present (except for asymptomatic urinary tract infections)...
See the full eligibility criteria
- 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...
- At least one measurable target lesion according to RECIST 1.1.
- Age 18 years or older, any gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Expected survival of at least 3 months.
- Within one week before enrollment, baseline blood tests should be essentially normal (no blood transfusions or hematopoietic growth factor treatment within 14 days): absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L...
- Within one week before enrollment, baseline liver and kidney function tests should be essentially normal (normal values determined by each study center's laboratory): total bilirubin (TBIL) ≤ 1.5 × upper limit of normal...
- Fertile patients (both males and females) must agree to use a reliable contraceptive method concurrently with their partners during the trial and for at least 3 months after the last dose of medication (hormonal or...
- Pre-menopausal women should provide blood and urine samples to confirm a negative pregnancy status and commit to using contraception during the study period and for 6 months after the study. Male participants are...
- Patients who have undergone major visceral surgery (excluding needle biopsies) or significant trauma within 4 weeks prior to the first administration of the study drug.
- Prior treatment with radiotherapy and two or more CDK4/6 inhibitors for advanced or metastatic disease.
- Failure to recover from adverse reactions of previous anti-tumor therapy to CTCAE 5.0 grade ≤ 1 (except for acceptable toxicities without safety risks, such as hair loss, and manageable immune-related adverse...
- Clinical symptoms of central nervous system metastases or leptomeningeal metastases, or other evidence indicating uncontrolled central nervous system metastases or leptomeningeal metastases deemed unsuitable for...
- Pregnancy (positive pregnancy test) or lactation.
- Active infection requiring systemic antimicrobial therapy that is not under control at present (except for asymptomatic urinary tract infections). History of immune deficiency, including positive HIV antibody testing...
- History of severe cardiovascular or cerebrovascular diseases, including but not limited to clinically significant cardiac rhythm or conduction abnormalities requiring clinical intervention, ventricular arrhythmias...
- Patients with psychiatric disorders or poor compliance.
- Patients unsuitable for hydroxychloroquine use due to the presence of retinal vascular disease.
- Other systemic medical history or conditions deemed inappropriate for participation in the trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.