Clinical trial • Phase III • Oncology
Gemcitabine for Non-muscle invasive bladder cancer (intermediate-risk)
Phase III trial of Gemcitabine for Non-muscle invasive bladder cancer (intermediate-risk).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-muscle invasive bladder cancer (intermediate-risk)
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 20-08-2024
- First CTIS Authorization Date
- 30-08-2024
Trial design
Randomised, open-label, test arm: gemcitabine accord 100 mg/ml concentrate for infusion (gemcitabine), intravesical use; test treatment: six adjuvant instillations (as stated in protocol synopsis). comparator arm: mitomycin medac, 40 mg, powder and solvent for intravesical solution (mitomycin), intravesical use; comparator treatment: six adjuvant instillations (standard).-controlled Phase III trial across 10 sites in Sweden.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Test arm: Gemcitabine Accord 100 mg/ml concentrate for infusion (Gemcitabine), intravesical use; Test treatment: six adjuvant instillations (as stated in protocol synopsis). Comparator arm: Mitomycin medac, 40 mg, powder and solvent for intravesical solution (Mitomycin), intravesical use; comparator treatment: six adjuvant instillations (standard).
- Target Sample Size
- 340
Eligibility
Recruits 340 isVulnerablePopulationSelected = true; exclusion criterion includes 'lack of informed consent'. Subject information and informed consent form available (L1_SIS and ICF)..
- Vulnerable Population
- isVulnerablePopulationSelected = true; exclusion criterion includes 'lack of informed consent'. Subject information and informed consent form available (L1_SIS and ICF).
Inclusion criteria
- {"criterion_text":"- Primary and recurrent non muscle invasive bladder cancer with intermediate risk of recurrence"}
Exclusion criteria
- {"criterion_text":"- Age below 18 years of age\n- lack of informed consent\n- Known allergy to either mitomycin or gemcitabine\n- Severe incontinence\n- Cronic urethral catheter"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Recurrence-free survival","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Local toxicity and HRQol two weeks after last installation, Progression-free survival, Health economy, Adverse events","definition_or_measurement_approach":"Secondary objectives: local side effects and HRQoL two weeks after the last instillation; HRQoL estimated with EORTC-QLQ-C30 + NMIBC24; Health economy measured with EQ-5D-5L; progression-free survival and adverse events as reported."}
Recruitment
- Planned Sample Size
- 340
- Recruitment Window Months
- 56
- Consent Approach
- Informed consent required; 'lack of informed consent' listed as an exclusion criterion. A Subject Information and Informed Consent Form (L1_SIS and ICF) document is available (for publication).
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 340
Sweden
- Earliest CTIS Part Ii Submission Date
- 29-03-2023
- Latest Decision Or Authorization Date
- 30-08-2024
- Processing Time Days
- 520
- Number Of Sites
- 10
- Number Of Participants
- 340
Sites
- Site Name
- Region Skane Helsingborg Hospital
- Department Name
- Urologikliniken
- Principal Investigator Name
- Mats Bläckberg
- Principal Investigator Email
- mats.blackberg@skane.se
- Contact Person Name
- Mats Bläckberg
- Contact Person Email
- mats.blackberg@skane.se
- Site Name
- Region Skane - Skanes Universitetssjukhus
- Department Name
- Urologkliniken Jan Waldenströms gata 5
- Principal Investigator Name
- Fredrik Liedberg
- Principal Investigator Email
- fredrik.liedberg@med.lu.se
- Contact Person Name
- Fredrik Liedberg
- Contact Person Email
- fredrik.liedberg@med.lu.se
- Site Name
- Region Skane Angelholms Sjukhus
- Department Name
- Urologmottagningen
- Principal Investigator Name
- Malin Böös
- Principal Investigator Email
- malin.boos@skane.se
- Contact Person Name
- Malin Böös
- Contact Person Email
- malin.boos@skane.se
- Site Name
- Region Kronoberg
- Department Name
- Urologmottagningen Ljungby lasarett, Kyrkogatan 2, Ljungby
- Principal Investigator Name
- Jonas Richthoff
- Principal Investigator Email
- jonas.richthoff@kronoberg.se
- Contact Person Name
- Jonas Richthoff
- Contact Person Email
- jonas.richthoff@kronoberg.se
- Site Name
- Region Joenkoepings Laen
- Department Name
- Urologmottagningen, Värnamo sjukhus
- Principal Investigator Name
- Emma Persson
- Principal Investigator Email
- emma.b.persson@rjl.se
- Contact Person Name
- Emma Persson
- Contact Person Email
- emma.b.persson@rjl.se
- Site Name
- Region Oerebro Laen
- Department Name
- Urologkliniken, Universitetssjukhuset Örebro, Södra Grev Rosengatan
- Principal Investigator Name
- Tomas Jerlström
- Principal Investigator Email
- tomas.jerlstrom@regionorebrolan
- Contact Person Name
- Tomas Jerlström
- Contact Person Email
- tomas.jerlstrom@regionorebrolan
- Site Name
- Region Kronoberg
- Department Name
- Kirurgmottagningen, Centrallasarettet Växjö, Strandvägen 8, Växjö
- Principal Investigator Name
- Joakim Örtegren
- Principal Investigator Email
- joakim.ortegren@kronoberg.se
- Contact Person Name
- Joakim Örtegren
- Contact Person Email
- joakim.ortegren@kronoberg.se
- Site Name
- Region Joenkoepings Laen
- Department Name
- Urologmottagningen, Länssjukhuset Ryhov
- Principal Investigator Name
- Emma Persson
- Principal Investigator Email
- emma.b.persson@rjl.se
- Contact Person Name
- Emma Persson
- Contact Person Email
- emma.b.persson@rjl.se
- Site Name
- Region Joenkoepings Laen
- Department Name
- Urologmottagningen, Höglandssjukhuset
- Principal Investigator Name
- Tomasz Jakubczyk
- Principal Investigator Email
- tomasz.jakubzyk@rjl.se
- Contact Person Name
- Tomasz Jakubczyk
- Contact Person Email
- tomasz.jakubzyk@rjl.se
- Site Name
- Region Skane Lasarettet I Landskrona
- Department Name
- Urologimottagningen
- Principal Investigator Name
- Mats Wokander
- Principal Investigator Email
- mats.wokander@skane.se
- Contact Person Name
- Mats Wokander
- Contact Person Email
- mats.wokander@skane.se
Sponsor
Primary sponsor
- Full Name
- Region Skane
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Third parties
- {"country":"Sweden","full_name":"Region Skane Skanes Universitetssjukhus","duties_or_roles":"sponsorDuties codes: 1,6","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Gemcitabine Accord 100 mg/ml Koncentrat till infusionsvätska, lösning
- Active Substance
- Gemcitabine
- Modality
- Small molecule
- Routes Of Administration
- Intravesical
- Route
- Intravesical
- Authorisation Status
- Authorised (marketing authorisation number: 45507)
- Maximum Dose
- 1000 mg (max daily); 6000 mg (max total)
- Investigational Product Name
- Mitomycin medac, 40 mg, pulver och vätska till intravesikal lösning
- Active Substance
- Mitomycin
- Modality
- Small molecule
- Routes Of Administration
- Intravesical
- Route
- Intravesical
- Authorisation Status
- Authorised (marketing authorisation number: 50421)
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg (max daily); 240 mg (max total)
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