Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077012
Status:
COMPLETED
Last Update Posted:
2012-05-23
First Post:
2004-02-09
Brief Title:
Dose Escalation Study With QLT0074 for Benign Prostatic Hyperplasia
Sponsor:
QLT Inc
Organization:
QLT Inc
Study Overview
Official Title:
A Phase III Dose Escalation Study to Assess the Safety Tolerability and Preliminary Efficacy of Transurethral Photodynamic Therapy With QLT0074 for Benign Prostatic Hyperplasia
Status:
COMPLETED
Status Verified Date:
2012-05
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:
The primary objective of this study is to assess the safety and tolerance of transurethral photodynamic therapy PDT with QLT0074
Secondary objectives are
1 To determine if transurethral PDT with QLT0074 has a therapeutic effect on benign prostatic hyperplasia BPH evaluated by the American Urological Association Symptom Index AUA SI urinary flow rate Qmax and post-void residual volume PVR
2 To determine the extent of systemic exposure to QLT0074 following transurethral intraprostatic injection
3 To select up to two transurethral PDT drug-light regimens for further clinical development
Secondary objectives are
1 To determine if transurethral PDT with QLT0074 has a therapeutic effect on benign prostatic hyperplasia BPH evaluated by the American Urological Association Symptom Index AUA SI urinary flow rate Qmax and post-void residual volume PVR
2 To determine the extent of systemic exposure to QLT0074 following transurethral intraprostatic injection
3 To select up to two transurethral PDT drug-light regimens for further clinical development
Detailed Description:
This will be a multicenter uncontrolled dose escalation exploratory study in subjects with symptomatic BPH Six study centers are planned
Each subject will receive a fixed dose of QLT0074 04 mg injected transurethrally into the prostate followed by transurethral light application to activate the drug Five light dose cohorts will be investigated sequentially 25 50 80 120 and 150 Jcm2 with 3 subjects in the first cohort and 6 subjects in cohorts 2-5 for a total of 27 subjects The follow-up period for each subject is 180 days There will be a minimum 30-day interval between treatment of the last subject in one cohort Day 0 and treatment of the first subject in the next cohort to monitor predefined toxicities and ensure safety and tolerance in subjects of the previous cohort
A Safety Monitoring Committee will evaluate toxicity related to PDT effects and approve escalation of the light dose for each cohort The light dose will not be escalated if any of the following predefined toxicity criteria occur and are judged to be related to a PDT effect by the Safety Monitoring Committee
1 1 or more subjects in the cohort experience macroscopic urinary bleeding not resolved by Day 14 or
2 2 or more subjects in the cohort experience intolerable urinary pain not controlled with over-the-counter medication by Day 14 or
3 1 or more subjects in the cohort experience any other clinically significant urological adverse event as judged by the Investigator and confirmed by the Safety Monitoring Committee
In addition to the above events the Safety Monitoring Committee will evaluate the incidence timing severity and frequency of other adverse events and serious adverse events to assess the safety of transurethral PDT and the treatment procedures such as the use of the cystoscope InjectTx device treatment balloon-catheter etc
To prevent treating subjects with a light dose greater than that which already provides substantial clinical benefit the Safety Monitoring Committee will review preliminary efficacy data AUA SI scores and Qmax values after all subjects in a cohort for each of the first 4 cohorts have completed the Day 90 visit Further enrollment will be curtailed if more than 75 of subjects in a cohort experience both of the following efficacy stopping criteria by Day 90
1 greater or equal to 75 reduction in the AUA SI score and
2 greater or equal to 100 increase in Qmax
Each subject will receive a fixed dose of QLT0074 04 mg injected transurethrally into the prostate followed by transurethral light application to activate the drug Five light dose cohorts will be investigated sequentially 25 50 80 120 and 150 Jcm2 with 3 subjects in the first cohort and 6 subjects in cohorts 2-5 for a total of 27 subjects The follow-up period for each subject is 180 days There will be a minimum 30-day interval between treatment of the last subject in one cohort Day 0 and treatment of the first subject in the next cohort to monitor predefined toxicities and ensure safety and tolerance in subjects of the previous cohort
A Safety Monitoring Committee will evaluate toxicity related to PDT effects and approve escalation of the light dose for each cohort The light dose will not be escalated if any of the following predefined toxicity criteria occur and are judged to be related to a PDT effect by the Safety Monitoring Committee
1 1 or more subjects in the cohort experience macroscopic urinary bleeding not resolved by Day 14 or
2 2 or more subjects in the cohort experience intolerable urinary pain not controlled with over-the-counter medication by Day 14 or
3 1 or more subjects in the cohort experience any other clinically significant urological adverse event as judged by the Investigator and confirmed by the Safety Monitoring Committee
In addition to the above events the Safety Monitoring Committee will evaluate the incidence timing severity and frequency of other adverse events and serious adverse events to assess the safety of transurethral PDT and the treatment procedures such as the use of the cystoscope InjectTx device treatment balloon-catheter etc
To prevent treating subjects with a light dose greater than that which already provides substantial clinical benefit the Safety Monitoring Committee will review preliminary efficacy data AUA SI scores and Qmax values after all subjects in a cohort for each of the first 4 cohorts have completed the Day 90 visit Further enrollment will be curtailed if more than 75 of subjects in a cohort experience both of the following efficacy stopping criteria by Day 90
1 greater or equal to 75 reduction in the AUA SI score and
2 greater or equal to 100 increase in Qmax
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None