Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Recruiting NCT04736394 - 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 Phase 3
Recruiting NCT05951179 - Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer Phase 2
Active, not recruiting NCT04943094 - Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy
Not yet recruiting NCT06227065 - Precise Neoadjuvant Chemoresection of Low Grade NMIBC Phase 2
Completed NCT02969109 - Validation of a Urine-based Assay With Genomic Markers for Predicting Recurrence for Non-muscle Invasive Bladder Cancer
Completed NCT01458847 - Cis-urocanic Acid (Cis-UCA) in Patients With Primary or Recurrent Non-muscle Invasive Bladder Cancer Phase 1
Recruiting NCT03914794 - A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors Phase 2
Recruiting NCT05126472 - Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment Phase 1
Recruiting NCT04644835 - Low Energy Shock Wave Therapy and Non-Muscle Invasive Bladder Cancer N/A
Recruiting NCT06126796 - Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
Active, not recruiting NCT04100733 - Surveillance of High-grade Non-muscle Invasive Bladder Tumours Using the Xpert Bladder Cancer Monitor N/A
Recruiting NCT05085990 - Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer Phase 1
Recruiting NCT03560479 - A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer Phase 1/Phase 2
Terminated NCT01310803 - Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder Phase 3
Completed NCT03081858 - Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer Phase 1/Phase 2
Recruiting NCT05337397 - Outpatient Laser Ablation of Recurrent Non-muscle Invasive Bladder Cancer
Active, not recruiting 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 Phase 3
Recruiting NCT04859751 - Study of VB4-845 Injection for Treating Patients With Non-muscle Invasive Bladder Cancer Phase 3
Recruiting NCT05672615 - Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Not yet recruiting NCT06245603 - A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer N/A