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Study of Continuous APL-1202 Treatment in Subjects With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Relapsed From Intravesical Chemo/BCG Therapy

Non-muscle Invasive Bladder Cancer Clinical Trial

Official title:
A Phase II Single-Arm, Open-Label, Multi-Center Study of Continuous APL-1202 Treatment in Subjects With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Relapsed From Intravesical Chemo/BCG Therapy

Clinical Trial Summary

To determine the efficacy of oral APL-1202 administered consecutively for 12 weeks in subjects with high-risk NMIBC relapsed from intravesical chemo/BCG therapy based on the recurrence-free rate (RFR) at 12 months after APL-1202 treatment.

Clinical Trial Description

This trial was a single-arm, open-label, multi-center clinical study consisting of two periods: the dose-escalation and treatment period, and the follow-up and maintenance period.

Dose-Escalation and Treatment Period APL-1202 was orally administered TID daily and continuously for 12 weeks. APL-1202 dose was increased from daily 300, 450, 600 to 750mg or maximum tolerated dose (MTD).

A modified 3+3 design was employed: The dose was started at 300 mg and increased to 450 mg, 600 mg and 750 mg if there was no dose-limiting toxicity (DLT) in 3 subjects after 4-week consecutive administration of APL-1202. When the dose-escalation study was in progress, the doses for any newly enrolled subjects would be the starting dose or the highest dose confirmed with no DLT by the dose-escalation cohort at the time of enrollment. When the MTD or the 750 mg daily dose was attained as a safe dose, the dose for all subjects in the study or subsequently enrolled subjects would be MTD or 750 mg/day.

Follow-up and Maintenance Period APL-1202 was orally administered at the highest safe dose proven by the dose-escalation cohort, continuously for 3 months; This period was 12 months. To fit the 3-month cystoscopy follow-up schedule, the maintenance therapy, starting from 3-month off, was given continuously every other 3 months, resulting in 6 months of dosing in total.

APL-1202 daily administration schedule:

The first dose: within 30 minutes after breakfast; The second dose: within 30 minutes after lunch, and there should be a 4-hour interval between the first and second doses; The third dose: taken with a light snack at night before going to bed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04498702
Study type Interventional
Source Jiangsu Yahong Meditech Co.,Ltd.
Contact
Status Completed
Phase Phase 2
Start date May 13, 2014
Completion date January 18, 2017
View Details
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