Trial Outcomes & Findings for Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ (NCT NCT00462488)
NCT ID: NCT00462488
Last Updated: 2020-05-12
Results Overview
Complete response rate in subjects with carcinoma in situ (CIS) non-muscle invasive bladder cancer (NMIBC) following the induction phase (3-month evaluation point) of Vicinium treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
12 or 13 weeks
Results posted on
2020-05-12
Participant Flow
Participant milestones
| Measure |
Treatment Schedule A -
Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.
If the subject had histologically confirmed disease that is stage \<T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study \[EOS\]).
Vicinium: Intravesical administration of Vicinium
|
Treatment Schedule B
Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy.
If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS).
Vicinium: Intravesical administration of Vicinium
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
Completed Induction Phase
|
22
|
23
|
|
Overall Study
Completed Induction 2/Maintenance 1
|
18
|
9
|
|
Overall Study
Completed Maintenance 2
|
7
|
6
|
|
Overall Study
COMPLETED
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
20
|
17
|
Reasons for withdrawal
| Measure |
Treatment Schedule A -
Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.
If the subject had histologically confirmed disease that is stage \<T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study \[EOS\]).
Vicinium: Intravesical administration of Vicinium
|
Treatment Schedule B
Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy.
If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS).
Vicinium: Intravesical administration of Vicinium
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
19
|
17
|
Baseline Characteristics
Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ
Baseline characteristics by cohort
| Measure |
Treatment Schedule A -
n=23 Participants
Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.
If the subject had histologically confirmed disease that is stage \<T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study \[EOS\]).
Vicinium: Intravesical administration of Vicinium
|
Treatment Schedule B
n=23 Participants
Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy.
If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS).
Vicinium: Intravesical administration of Vicinium
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Continuous
|
71.6 years
n=5 Participants
|
71.5 years
n=7 Participants
|
71.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 or 13 weeksPopulation: One subject in Treatment Schedule A was not evaluated for complete response after the induction phase as they were ineligible to be on trial and therefore discontinued after receiving one dose of study drug.
Complete response rate in subjects with carcinoma in situ (CIS) non-muscle invasive bladder cancer (NMIBC) following the induction phase (3-month evaluation point) of Vicinium treatment
Outcome measures
| Measure |
Treatment Schedule A -
n=22 Participants
Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.
If the subject had histologically confirmed disease that is stage \<T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study \[EOS\]).
Vicinium: Intravesical administration of Vicinium
|
Treatment Schedule B
n=23 Participants
Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy.
If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS).
Vicinium: Intravesical administration of Vicinium
|
|---|---|---|
|
Treatment Schedule A: 12-Week Efficacy, Treatment Schedule B: 13-Week Efficacy
|
40.9 percentage of patients
Interval 20.7 to 63.6
|
39.1 percentage of patients
Interval 19.7 to 61.5
|
Adverse Events
Treatment Schedule A -
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Treatment Schedule B
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Schedule A -
n=23 participants at risk
Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.
If the subject had histologically confirmed disease that is stage \<T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study \[EOS\]).
Vicinium: Intravesical administration of Vicinium
|
Treatment Schedule B
n=23 participants at risk
Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy.
If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS).
Vicinium: Intravesical administration of Vicinium
|
|---|---|---|
|
Renal and urinary disorders
urinary retention
|
4.3%
1/23 • Number of events 1 • 60 weeks
|
0.00%
0/23 • 60 weeks
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
0.00%
0/23 • 60 weeks
|
4.3%
1/23 • Number of events 1 • 60 weeks
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/23 • 60 weeks
|
4.3%
1/23 • Number of events 1 • 60 weeks
|
|
Renal and urinary disorders
Extravasation during TURBT
|
0.00%
0/23 • 60 weeks
|
4.3%
1/23 • Number of events 1 • 60 weeks
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/23 • 60 weeks
|
4.3%
1/23 • Number of events 1 • 60 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/23 • 60 weeks
|
4.3%
1/23 • Number of events 1 • 60 weeks
|
Other adverse events
| Measure |
Treatment Schedule A -
n=23 participants at risk
Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.
If the subject had histologically confirmed disease that is stage \<T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study \[EOS\]).
Vicinium: Intravesical administration of Vicinium
|
Treatment Schedule B
n=23 participants at risk
Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy.
If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS).
Vicinium: Intravesical administration of Vicinium
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23 • Number of events 1 • 60 weeks
|
13.0%
3/23 • Number of events 3 • 60 weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Number of events 1 • 60 weeks
|
8.7%
2/23 • Number of events 2 • 60 weeks
|
|
General disorders
Fatigue
|
21.7%
5/23 • Number of events 12 • 60 weeks
|
21.7%
5/23 • Number of events 5 • 60 weeks
|
|
General disorders
Influenza like illness
|
17.4%
4/23 • Number of events 4 • 60 weeks
|
8.7%
2/23 • Number of events 4 • 60 weeks
|
|
General disorders
Localized Oedema
|
0.00%
0/23 • 60 weeks
|
13.0%
3/23 • Number of events 4 • 60 weeks
|
|
General disorders
Pyrexia
|
13.0%
3/23 • Number of events 4 • 60 weeks
|
8.7%
2/23 • Number of events 2 • 60 weeks
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
2/23 • Number of events 2 • 60 weeks
|
8.7%
2/23 • Number of events 2 • 60 weeks
|
|
Infections and infestations
Urinary tract infection
|
13.0%
3/23 • Number of events 4 • 60 weeks
|
26.1%
6/23 • Number of events 11 • 60 weeks
|
|
Investigations
Blood urine present
|
8.7%
2/23 • Number of events 2 • 60 weeks
|
13.0%
3/23 • Number of events 5 • 60 weeks
|
|
Investigations
Cells in urine
|
8.7%
2/23 • Number of events 2 • 60 weeks
|
4.3%
1/23 • Number of events 1 • 60 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
2/23 • Number of events 2 • 60 weeks
|
17.4%
4/23 • Number of events 10 • 60 weeks
|
|
Nervous system disorders
Dizziness
|
13.0%
3/23 • Number of events 4 • 60 weeks
|
8.7%
2/23 • Number of events 2 • 60 weeks
|
|
Renal and urinary disorders
Bladder pain
|
13.0%
3/23 • Number of events 5 • 60 weeks
|
8.7%
2/23 • Number of events 3 • 60 weeks
|
|
Renal and urinary disorders
Dysuria
|
47.8%
11/23 • Number of events 18 • 60 weeks
|
73.9%
17/23 • Number of events 53 • 60 weeks
|
|
Renal and urinary disorders
Haematuria
|
34.8%
8/23 • Number of events 16 • 60 weeks
|
21.7%
5/23 • Number of events 9 • 60 weeks
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
8.7%
2/23 • Number of events 2 • 60 weeks
|
4.3%
1/23 • Number of events 4 • 60 weeks
|
|
Renal and urinary disorders
Micturition urgency
|
13.0%
3/23 • Number of events 4 • 60 weeks
|
30.4%
7/23 • Number of events 8 • 60 weeks
|
|
Renal and urinary disorders
Nocturia
|
8.7%
2/23 • Number of events 2 • 60 weeks
|
21.7%
5/23 • Number of events 8 • 60 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
13.0%
3/23 • Number of events 3 • 60 weeks
|
34.8%
8/23 • Number of events 10 • 60 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
4.3%
1/23 • Number of events 1 • 60 weeks
|
13.0%
3/23 • Number of events 3 • 60 weeks
|
|
Vascular disorders
Hypertension
|
13.0%
3/23 • Number of events 3 • 60 weeks
|
4.3%
1/23 • Number of events 1 • 60 weeks
|
|
Vascular disorders
Hypotension
|
13.0%
3/23 • Number of events 3 • 60 weeks
|
0.00%
0/23 • 60 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60