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Virus Therapy
ADSTILADRIN for Bladder Cancer
Phase 3
Waitlist Available
Led By Stephen Boorjian, MD
Research Sponsored by Ferring Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new, high-dose treatment for patients with a type of bladder cancer that doesn't respond well to other treatments.
Eligible Conditions
- Bladder Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Patients With a Complete Response Rate Based on Patients With Carcinoma in Situ (CIS), With or Without Concomitant High-grade Ta or T1 Papillary Disease.
Secondary study objectives
Anti-adenoviral Antibody Levels for Correlation to Response Rate
Durability of Complete Response in Patients With CIS (With or Without Concomitant Ta or T1 Papillary Disease) Who Achieve a Complete Response.
Durability of High-grade-recurrence-free Survival in Patients With High-grade Ta or T1 Papillary Disease (With or Without Concomitant CIS)
+5 moreSide effects data
From 2023 Phase 3 trial • 157 Patients • NCT0277384930%
Instillation site discharge
24%
Urinary tract infection
18%
Micturition urgency
18%
Bladder spasm
16%
Fatigue
16%
Dysuria
16%
Headache
14%
Pyrexia
14%
Diarrhoea
14%
Haematuria
12%
Chills
12%
Dizziness
12%
Pollakiuria
10%
Bronchitis
10%
Myalgia
10%
Abdominal pain
8%
Malaise
8%
Influenza like illness
8%
Night sweats
8%
Arthralgia
8%
Cough
8%
Back pain
8%
Nausea
6%
Decreased appetite
6%
Hypoaesthesia
6%
Vomiting
6%
Hypertension
6%
Urinary retention
6%
Nocturia
6%
Constipation
6%
Sinusitus
6%
Bladder pain
4%
Pain
4%
Nasopharyngitis
2%
Procedural pain
2%
Transitional cell cancer of the renal pelvis and ureter
2%
Cardiac failure
2%
Myocardial infarction
2%
Anaphylactic reaction
2%
Pneumonia
2%
Sepsis
2%
Corneal abrasion
2%
Hypoglycaemia
2%
Transient global amnesia
2%
Subcutaneous emphysema
2%
Urinary incontinence
2%
Pericarditis
2%
Bile duct stone
2%
Coronary Artery Disease
2%
Lung neoplasm malignant
2%
Syncope
2%
Lung cancer metastatic
2%
Pancreatic carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Papillary Disease (Without Concomitant CIS)
Carcinoma in Situ (CIS)
Total TEAE
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ADSTILADRINExperimental Treatment1 Intervention
Intravesical administration of ADSTILADRIN into the bladder
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADSTILADRIN
2016
Completed Phase 3
~160
Find a Location
Who is running the clinical trial?
Ferring PharmaceuticalsLead Sponsor
322 Previous Clinical Trials
1,242,094 Total Patients Enrolled
FKD Therapies OyIndustry Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Society of Urologic Oncology Clinical Trials ConsortiumOTHER
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