Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04498702
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2020-07-22
Brief Title:
Study of Continuous APL-1202 Treatment in Subjects With High-Risk Non-Muscle-Invasive Bladder Cancer NMIBC Relapsed From Intravesical ChemoBCG Therapy
Sponsor:
Jiangsu Yahong Meditech Co Ltd aka Asieris
Organization:
Jiangsu Yahong Meditech Co Ltd aka Asieris
Study Overview
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 ChemoBCG Therapy
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the efficacy of oral APL-1202 administered consecutively for 12 weeks in subjects with high-risk NMIBC relapsed from intravesical chemoBCG therapy based on the recurrence-free rate RFR at 12 months after APL-1202 treatment
Detailed 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 33 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 mgday
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
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 33 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 mgday
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None