RE:RE:He (she) cares about us investorsOur clown is still playing the innocent cart again + not explaining his entire post removals by SH. We investors would like to know your side of the story, because ...
in You we trust. Also, as a storyteller you left out some vital information in one of your last "quality" post.
Tell us investors why ?
In yellow my adjustments.
Primary Outcome Measures:
- Assessment of Safety: Evaluation of the safety of TLD1433 will be assessed with the incidence and severity of Adverse Effects [ Time Frame: Up to the completion of follow-up phase (180 days) ]
Hematology, blood chemistry, and urinalysis for safety purposes will be performed at days 1, 3, 30, 60, 90 and 180 as well as at the time of premature discontinuation. Troponin testing will only be performed at day 1, 3, and 30.
CT scan will be performed at Day 30 and Day 180 to identify possible tissue reaction to PDT.
ECG will be performed at baseline, during the study treatment and Day 1 (24 hours) after study treatment. An additional ECG will be performed at 8 hours ± 15 minutes post-drug instillation to correspond with the 8 hour PK blood sample at Day 0.
Vital signs (blood pressure, heart rate, respiratory rate and temperature) will be recorded for safety purposes at every visit throughout treatment and at the end of study.
A comprehensive physical examination for safety purposes is required during Screening and at the Month 6/End of Study and End of Treatment.
Multiple measurements will be aggregated into number of abnormal results different from baseline for each subject.
Secondary Outcome Measures:
- Pharmacokinetics of TLD1433 in blood and urine (Cmax) [ Time Frame: Blood (prior to drug, 1h, 4h, 8h, 24h, and 72h post drug). Urine (prior to drug, 8h, 24h, and 72h post drug) ]
Pharmacokinetics (PK) of TLD1433 will be assessed with the maximum observed concentration (Cmax) in blood and urine.
- Pharmacokinetics of TLD1433 in blood and urine (area under curve) [ Time Frame: Blood (prior to drug, 1h, 4h, 8h, 24h, and 72h post drug). Urine (prior to drug, 8h, 24h, and 72h post drug) ]
Pharmacokinetics (PK) of TLD1433 will be assessed with the area under the curve from time zero to the last quantifiable concentration (AUC0-t) in blood and urine.
Other Outcome Measures:
- Efficacy: Recurrence is defined as the interval from Day 0 to documented recurrence [ Time Frame: The overall efficacy will be evaluated during the course of the study (at 3 and 6 months) ]
Recurrence is defined as any new tumour growth, i.e. any biopsy-confirmed new or recurrent tumour, or positive saline bladder washing cytology.
Recurrence endpoint is either:
- Recurrence-free survival rate at 3 and 6 months.
- Recurrence rate at 3 and 6 months.
- Efficacy: Survival is defined as the interval from Day 0 to documented survival or death of any cause. [ Time Frame: The overall survival will be evaluated during the course of the study (at 3 and 6 months) ]
Survival endpoints is either:
- Overall survival during the course of the study.
- Overall survival rate at 3 and 6 months.
| Estimated Enrollment: | 9 |
| Actual Study Start Date: | December 21, 2016 |
| Estimated Study Completion Date: | December 1, 2017 |
| Estimated Primary Completion Date: | December 1, 2017 (Final data collection date for primary outcome measure) |