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ADSTILADRIN for Bladder Cancer (ABLE-41 Trial)

N/A
Recruiting
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 up to 2 years
Awards & highlights

Summary

Multi-center, prospective non-interventional study to collect data on the early use of Adstiladrin in the US \& Israel. Data will be collected from patients and prescribing physicians in a real-world setting

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Customized physician surveys (at 1 month following first patient first instillation of ADSTILADRIN, or as soon as possible upon site activation, and at 12 and 24 months post first patient first instillation at each respective site)
Patients' caregiver experience as measured by WPAI:CG (administered at the same timepoints as the patients)
Proportion of patients with pre-specified biomarker tested in the routine care setting, along with timing, type of sampling and laboratory results

Side effects data

From 2023 Phase 3 trial • 157 Patients • NCT02773849
30%
Instillation site discharge
24%
Urinary tract infection
18%
Micturition urgency
18%
Bladder spasm
16%
Dysuria
16%
Fatigue
16%
Headache
14%
Pyrexia
14%
Diarrhoea
14%
Haematuria
12%
Chills
12%
Dizziness
12%
Pollakiuria
10%
Bronchitis
10%
Myalgia
10%
Abdominal pain
8%
Nausea
8%
Night sweats
8%
Arthralgia
8%
Influenza like illness
8%
Back pain
8%
Cough
8%
Malaise
6%
Urinary retention
6%
Vomiting
6%
Sinusitus
6%
Nocturia
6%
Constipation
6%
Decreased appetite
6%
Hypoaesthesia
6%
Hypertension
6%
Bladder pain
4%
Pain
4%
Nasopharyngitis
2%
Pneumonia
2%
Hypoglycaemia
2%
Transient global amnesia
2%
Corneal abrasion
2%
Transitional cell cancer of the renal pelvis and ureter
2%
Procedural pain
2%
Urinary incontinence
2%
Cardiac failure
2%
Sepsis
2%
Subcutaneous emphysema
2%
Anaphylactic reaction
2%
Myocardial infarction
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: ADSTILADRINExperimental Treatment1 Intervention
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
321 Previous Clinical Trials
1,243,079 Total Patients Enrolled
Global Clinical ComplianceStudy DirectorFerring Pharmaceuticals
69 Previous Clinical Trials
1,159,396 Total Patients Enrolled
~444 spots leftby Dec 2025
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