Bladder CancerNCT01314664
A Prospective Registry to Assess the Effectiveness and Local Tolerability of Intravesical Valrubicin in Subjects With Non-muscle Invasive Bladder Cancer (NMIBC)
An observational study of Bladder Cancer and CIS, run by Endo USA Inc., a Keenova Therapeutics Company at 11 sites in United States.
Trial summary
The purpose of this study is to observe and describe the effectiveness and local tolerability of intravesical treatment with valrubicin for non-muscle invasive bladder cancer (NMIBC) in a cohort of subjects treated under routine practice conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, CIS
- How many people
- 15 participants
- Where
- 11 sitesUnited States
- Study dates
- May 2011to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects who will be receiving intravesical valrubicin treatment for NMIBC
Who may be able to join
- Males and females 18 years of age and older
- Diagnosed with NMIBC
- Prescribed intravesical valrubicin to treat NMIBC
- Understood and signed Informed Consent to participate
Who cannot join
- None
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Urology Associates of North Texas
Arlington, Texas, 76017
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, 19004
Long Island Urological Associates
Bethpage, New York, 11714
Urology Clinics of North Texas
Dallas, Texas, 75231
Urology Research Network
Hialeah, Florida, 33149
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Kansas City Urology Care
Overland Park, Kansas, 66211
BCG Oncology
Phoenix, Arizona, 85032
Delaware Valley Urology
Sewell, New Jersey, 08080
Advanced Urology Association of Florida
Vero Beach, Florida, 32960
Delaware Valley Urology
Voorhees Township, New Jersey, 08043
About this study
Official title: A PROSPECTIVE REGISTRY TO ASSESS THE EFFECTIVENESS AND LOCAL TOLERABILITY OF INTRAVESICAL VALRUBICIN IN SUBJECTS WITH NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)
The purpose of this study is to observe and describe the effectiveness and local tolerability of intravesical treatment with valrubicin for non-muscle invasive bladder cancer (NMIBC) in a cohort of subjects treated under routine practice conditions.
- Conditions
- Bladder Cancer, CIS
- Keywords
- Non-Muscle Invasive Bladder Cancer, CIS, BCG Refractory
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Business decision, not safety related
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Kirby, PhD, Study director, Endo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314664
- Sponsor's protocol ID
- EN3329-402
- Status last verified
- Jun 2015
- First submitted
- 11 Mar 2011
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROSPECTIVE REGISTRY TO ASSESS THE EFFECTIVENESS AND LOCAL TOLERABILITY OF INTRAVESICAL VALRUBICIN IN SUBJECTS WITH NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)
- ClinicalTrials.gov ID
- NCT01314664
- Acronym / sponsor ID
- EN3329-402
- Conditions
- Bladder Cancer, CIS
- Keywords
- Non-Muscle Invasive Bladder Cancer, CIS, BCG Refractory
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision, not safety related
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to observe and describe the effectiveness and local tolerability of intravesical treatment with valrubicin for non-muscle invasive bladder cancer (NMIBC) in a cohort of subjects treated under routine practice conditions.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects who will be receiving intravesical valrubicin treatment for NMIBC
Key inclusion criteria (4 listed)
- Males and females 18 years of age and older
- Diagnosed with NMIBC
- Prescribed intravesical valrubicin to treat NMIBC
- Understood and signed Informed Consent to participate
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Business decision, not safety related). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Kirby, PhD study director
Endo
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and CIS, run by Endo USA Inc., a Keenova Therapeutics Company at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business decision, not safety related). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2015.