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A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients

NCT04736394 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2022-02-22

No results posted yet for this study

Summary

A multi-center, randomized, open-label, parallel-controlled Phase Ⅲ clinical trial to evaluate the clinical safety and efficacy of APL-1202 as a single-agent oral treatment versus intravesical instillation of Epirubicin hydrochloride in naïve intermediate-risk non-muscle invasive bladder cancer (NMIBC) patients

Conditions

Interventions

DRUG

APL-1202

APL-1202 single-agent oral treatment

DRUG

Epirubicin Hydrochloride

Epirubicin hydrochloride

Sponsors & Collaborators

  • Jiangsu Yahong Meditech Co., Ltd aka Asieris

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-29
Primary Completion
2025-03-01
Completion
2025-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04736394 on ClinicalTrials.gov