NCT06890832

A Study to Investigate Efficacy and Safety of Different Dose Regimen of Oral Cabazitaxel Tablet in Adult Participants with Prostate Cancer

A Phase-2, Open-label, Randomized, Parallel-Group, Three-Arm Study to Assess Efficacy and Safety of Cabazitaxel Lipid Tablet in Combination with Prednisone for the Treatment of Adult Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with a Docetaxel-containing Treatment Regimen

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Jina Pharmaceuticals Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A total of 75 participants will be enrolled in the study, with 25 participants allocated per intervention group. In Group 1, participant will take 50 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 2, participant will take 100 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 3, participant will take 200 mg cabazitaxel every 3 weeks for 6 cycles (1 doses per cycle), 10 mg prednisone daily till the end of cycle 6. The study comprises three phases: a 21-day screening phase, an 18-week intervention phase starting on Day 1 (baseline), and a post-intervention follow-up phase lasting up to 12 months from Day 1. The total duration of participation for each individual will be approximately one year. Key efficacy assessments include CT scans/MRI, bone scans, PSA, ALP, LDH, symptomatic skeletal events, and pain evaluations. Key safety assessments encompass the monitoring of adverse events (AEs), ECOG performance status, physical examinations, vital sign measurements, clinical laboratory tests, peripheral neuropathy evaluation, 12-lead ECG, and echocardiogram (ECHO) assessments. Pharmacokinetic parameters will also be evaluated.

Conditions

• Metastatic Castration-resistant Prostate Cancer, MCRPC

Interventions

Type	Name	Description
DRUG	50 mg cabazitaxel	50 mg cabazitaxel to be taken every week for 6 cycles (3 doses per cycle), 10 mg prednisone to be taken daily till end of cycle 6
DRUG	100 mg cabazitaxel	100 mg cabazitaxel to be taken every week for 6 cycles (3 doses per cycle), 10 mg prednisone to be taken daily till end of cycle 6
DRUG	200 mg cabazitaxel	200 mg cabazitaxel to be taken every 3-week for 6 cycles (1 dose per cycle), 10 mg prednisone to be taken daily till end of cycle 6

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2025-03-24
• Last updated: 2025-03-24

Regulatory

• FDA-regulated drug study