NCT04490993

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 359 (actual)
• Sponsor: Jiangsu Yahong Meditech Co., Ltd aka Asieris · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

A multi-center, randomized, double-blind, placebo controlled Phase Ⅲ trial; including 3 stages: screening period, treatment period, and follow-up period. * Screening period: 6 weeks prior to treatment * Treatment period: * 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

Conditions

• Non-muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	APL-1202 in combination with Epirubicin	* 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
DRUG	Placebo in combination with Epirubicin	* 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

Timeline

• Start date: 2017-03-30
• Primary completion: 2022-05-30
• Completion: 2022-05-30
• First posted: 2020-07-29
• Last updated: 2022-02-22

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study