CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
APL-1202 treatmentdrug
Likely dose
APL-1202 treatment 300 mgfrom 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/NCT04498702
NCT04498702Phase 2Completed
CompareCT.gov

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

Jiangsu Yahong Meditech Co., Ltd aka Asieris·interventional·Posted Aug 4, 2020·Updated Aug 13, 2020

In Brief

A Phase 2 clinical trial evaluating APL-1202 treatment for Non-muscle Invasive Bladder Cancer. Completed, enrolled 41 participants.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 4, 2020
Enrollment StartMay 13, 2014
Primary CompletionJan 18, 2017
TodayJul 1, 2026
Enrollment to primary: 2.7 yearsPosted 5.9 years ago

Interventions

APL-1202 treatmentdrug

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.