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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
No Placebo-Only Group

Summary

Multi-center, prospective non-interventional study to collect data on the early use of Adstiladrin in the US and 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
35%
Instillation site discharge
27%
Fatigue
21%
Bladder spasm
19%
Micturition urgency
18%
Haematuria
17%
Chills
17%
Pyrexia
16%
Dysuria
15%
Headache
10%
Urinary tract infection
9%
Diarrhoea
8%
Pain
8%
Pollakiuria
8%
Bladder pain
7%
Nausea
7%
Dizziness
7%
Hypertension
7%
Nasopharyngitis
7%
Urinary incontinence
7%
Myalgia
6%
Arthralgia
6%
Procedural pain
4%
Urinary retention
4%
Back pain
4%
Influenza like illness
4%
Nocturia
3%
Vomiting
3%
Sinusitus
2%
Decreased appetite
2%
Malaise
2%
Abdominal pain
1%
Cough
1%
Bronchitis
1%
Hypoaesthesia
1%
Acute coronary syndrome
1%
Atrial fibrillation
1%
Coronary Artery Disease
1%
Sepsis
1%
Arrhythmia
1%
Dehydration
1%
Atrial Flutter
1%
Translational cell carcinoma
1%
Brain oedema
1%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carcinoma in Situ (CIS)
Papillary Disease (Without Concomitant CIS)
Total TEAE

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
322 Previous Clinical Trials
1,241,851 Total Patients Enrolled
Global Clinical ComplianceStudy DirectorFerring Pharmaceuticals
70 Previous Clinical Trials
1,158,168 Total Patients Enrolled
~178 spots leftby Dec 2025
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