Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Palbociclib and Hydroxychloroquine in Advanced Solid Tumors
NCT05953350Phase 2
Key facts
- Status
- Recruiting
- Start
- Nov 2023
- Primary completion
- May 2024
- Countries
- 1
- Sponsor
- Sun Yat-sen Memorial Hospital
- Modality
- Small Molecules
- Conditions
- breast cancerLiposarcomasolid tumor
01
Overview
Phase 2, open-label trial of palbociclib and hydroxychloroquine in breast cancer, Liposarcoma and solid tumor (2 arms), sponsored by Sun Yat-sen Memorial Hospital. Primary endpoints: Maximum Tolerated Dose / Maximum Administered Dose at 12 months and Recommended Phase 2 Dose at 12 months. Started Nov 2023; status: recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Phase Ib Dose Escalation
HCQ 600mg BID + Palbociclib (100, 150, or 200 mg QD)
Phase II Expansion
HCQ 600mg BID + Palbociclib (RP2D)
03
Who it enrols
Patients with advanced solid tumors (including breast cancer and liposarcoma) who have failed prior CDK4/6 inhibitor therapy, with adequate organ function and no significant cardiovascular or retinal disease.
04
Endpoints
Primary
Maximum Tolerated Dose / Maximum Administered Dose
Recommended Phase 2 Dose
Secondary
Objective Response Rate
Progression-Free Survival
Beyond the preview
Go deeper on NCT05953350.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT05953350.