A study to investigate a new drug called Nintedanib for patients who have bladder cancer that has spread to the deeper walls of the bladder
- Conditions
- Muscle invasive bladder cancer - localised muscle invasive carcinoma (T2-T4a N0 M0)MedDRA version: 19.0Level: LLTClassification code 10022877Term: Invasive bladder cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004895-21-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 0
•Aged 18 or over
•Histologically proven invasive TCC of bladder
•Localised muscle invasive carcinoma
•ECOG performance status grade 0 to 1
•Adequate haematological function as evidenced by:
a) Haemoglobin >10.0g/dl
b) White blood cell count >3.0 x10 9/L
c) Absolute neutrophil count >1.5 x10 9/L
d) Platelet count >100,000/mm3
•Adequate Hepatic function as evidenced by:
a) Total Bilirubin <1.5 xULN
b) Alkaline Phosphatase (ALP) levels <2 xULN
c) Aspartate transaminase (AST)/Alanine transaminase (ALT) levels <3.0 xULN
•Glomerular Filtration Rate (GFR) > 60ml/min* measured by either**:
a)EDTA clearance
b)24 hr Urine collection
c)The Cockcroft-Gault calculation
As per local standard practice;
Available for 12-month follow up
•Agree to use adequate contraception which they agree to continue for 3 months after the study treatment
• Suitable for treatment with Gemcitabine and Cisplatin
•Able to receive radical treatment
•Able to provide written informed consent
*Following safety review from the safety sub-study, the ISDMC and the funder will decide whether the data indicates that it is suitable for patients with impaired GFR (40-60 ml/minute) to be included in the trial using split dose cisplatin 35 mg/m2 on day 1 and day 8 and which dose of Nintedanib/Placebo will be used for the main study.
**The same method used to measure GFR at screening should be used for each patient throughout the trial.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
•Pregnant or breast feeding
•Concomitant or previous malignancy which is likely to interfere with protocol treatment
•Evidence of significant clinical disorder, or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial.
•Male and female patients (of childbearing potential* not using adequate contraception and do not agree to do so for 3 months following Nintedanib treatment
• Evidence of metastatic disease
•Patients who require therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid <325 mg per day)
•Hypersensitivity to nintedanib, peanut or soya, or to any of the excipients of nintedanib
* Patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years.
Note Patients with hydronephrosis can be included if the kidney/ureter
has been stented, or nephrostomy has been inserted, and renal
function has been maintained to allow neoadjuvant chemotherapy
to be administered satisfactorily
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does treatment with a new drug called Nintedanib (used in combination with standard treatment) help to improve the removal of cancer cells from the sample of bladder tissue taken from the patient compared to if the patient were to receive standard treatment alone.;Primary end point(s): Pathological Complete Response;Timepoint(s) of evaluation of this end point: Last patient, end of cycle 3;Secondary Objective: Can the time in which the disease does not get any worse be extended for a patient by using a new drug called Nintedanib (used in combination with standard treatment) compared to if the patient were to receive standard treatment alone.<br><br>Does treatment with a new drug called Nintedanib (used in combination with standard treatment) help to prolong how long a patient lives for compared to if the patient were to receive standard treatment alone.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Progression free survival (defined as the date of randomisation to date of confirmed progression or death from any cause)<br>-Toxicity;Timepoint(s) of evaluation of this end point: -2 years & 5 years<br>-2 years & 5 years<br>-LPLV