Clinical Trial

Penfluridol for Relapsed/Refractory Small Cell Cancers

Not Yet Recruiting Phase 1/2
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Summary
Penfluridol for Relapsed/Refractory Small-Cell Carcinoma of the Lung or Cervix: A Multicenter, Open-Label, Single-Arm Phase Ib/II Trial This study evaluates the safety and anti-tumor activity of oral penfluridol, a first-generation antipsychotic that pre-clinically inhibits small-cell carcinoma (SCC) growth via DRD2 blockade, metabolic reprogramming and apoptosis induction. After ≥2 prior systemic regimens, 33 adult patients (18-75 y) with measurable, metastatic or recurrent lung or cervical SCC will be enrolled across five Chinese centers. A 3+3 dose-escalation (Ib) will establish the recommended Phase II dose (RP2D); an expansion cohort (II) will examine objective response rate (ORR, RECIST 1.1). Secondary end-points include duration of response, progression-free survival, overall survival, safety and exploratory biomarkers. Key inclusion: ECOG 0-1, adequate organ function, no active brain metastases. Penfluridol is administered once weekly, dose-escalated from 20 mg to RP2D, continued until progression or intolerance. Patients receive free study drug, PET imaging and laboratory monitoring.
Trial Details
NCT Number NCT07206563
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Small Cell Carcinoma, Small Cell Carcinoma of Lung, Small Cell Lung Cancer ( SCLC ), Small Cell Cervical Carcinoma
Enrollment 33 participants
Start Date 2025-10-01
Primary Completion 2027-10-01 (estimated)
Study Completion 2028-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-10-03