CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 359 enrolled
Drug / intervention
APL-1202 in combination with Epirubicin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04490993
NCT04490993Phase 3Unknown
CompareCT.gov

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Trial to Evaluate the Clinical Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients

Jiangsu Yahong Meditech Co., Ltd aka Asieris·interventional·Posted Jul 29, 2020·Updated Feb 22, 2022

In Brief

A Phase 3 clinical trial evaluating APL-1202 in combination with Epirubicin and Placebo in combination with Epirubicin for Non-muscle Invasive Bladder Cancer. Targeting 359 participants across 1 site.

Detailed Summary

To evaluate the clinical efficacy (median event-free survival) of APL-1202 in combination with Epirubicin hydrochloride versus Epirubicin hydrochloride alone in intermediate and high-risk chemo-refractory non-muscle invasive bladder cancer (NMIBC) patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-muscle Invasive Bladder Cancer
CountriesChina
Collaborators--

Timeline

Phase 3UnknownOverdue
2017201820192020202120222023202420252026
First PostedJul 29, 2020
Enrollment StartMar 30, 2017
Primary CompletionMay 30, 2022
TodayJul 1, 2026
Enrollment to primary: 5.2 yearsPosted 5.9 years ago

Interventions

APL-1202 in combination with Epirubicindrug

* Induction period: APL-1202 is administered for 12 consecutive weeks * Maintenance period: after 12-week drug free period, APL-1202 is administered for another12 consecutive weeks as maintenance treatment * Follow up period: APL-1202 is administered at every 3-month interval if no events occurred in the treatment period and until the occurrence of events or the end of the entire clinical trial Intravesical Epirubicin hydrochloride will be administered once weekly for consecutive 6-8 weeks in the induction period, followed by once monthly in the maintenance period until end of 12 months

Placebo in combination with Epirubicindrug

* Induction period: placebo is administered for 12 consecutive weeks * Maintenance period: after 12-week drug free period, placebo is administered for another12 consecutive weeks as maintenance treatment * Follow up period: APL-1202 is administered at every 3-month interval if no events occurred in the treatment period and until the occurrence of events or the end of the entire clinical trial Intravesical Epirubicin hydrochloride will be administered once weekly for consecutive 6-8 weeks in the induction period, followed by once monthly in the maintenance period until end of 12 months