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

NCT06890832 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-03-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jina Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06890832 on ClinicalTrials.gov