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Bladder CancerPhase 1/2JaNEONCT02845050

Phase Ib/II Study Assessing the Neo-adjuvant Combination Therapy of Vinflunine With Cisplatin Followed by Radical Cystectomy in Patients With Muscle-invasive Bladder Cancer (JaNEO)

A Phase 1/2 study testing Vinflunine, Cisplatin and Radical cystectomy in people with Bladder Cancer, run by Ligartis GmbH at 2 sites in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Phase Ib/II study assessing the neo-adjuvant combination therapy of vinflunine with cisplatin followed by radical cystectomy in patients with muscle-invasive bladder cancer (JaNEO). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Bladder Cancer
What is being tested?
Vinflunine, Cisplatin and Radical cystectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesGermany
Study dates
Jul 2016to Jul 2017
Phase
Phase 1/2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged ≥ 18 years and ≤ 75 years with legal capacity
  • Signed written informed consent
  • Histologically confirmed muscle-invasive urothelial cell carcinoma of the bladder (MIBC) with clinical T2-T4a (N0/Nx, M0) assessed by primary PDD-guided TUR-B and by the screening imaging (MRI pelvis and CT chest/abdomen) which both must include the use of contrast medium
  • Confirmed adequate complete resection of all visible tumor during TUR-B according to current treatment guidelines before registration; the latest TUR-B must have been done ≤ 8 weeks before registration
  • ECOG performance status of 0 or 1
  • Adequate bone marrow, renal and hepatic functions as evidenced by the following:
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  • Absolute Neutrophil Count ≥ 2,000 mm3 and ≤ 7,500 mm3
  • Hemoglobin ≥ 12 g/dL for the safety phase of the study; if the study treatment proved to be adequate tolerated during this safety phase, the threshold can be lowered to ≥ 10 g/dL according to the decision of the study steering committee
  • Platelet count ≥ 100,000 mm3
  • Serum albumin within normal range
  • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Transaminases (ALT, AST) ≤ 1.5 x ULN
  • Creatinine clearance ≥ 60 mL/min, calculated based on a 24h-measured creatinine clearance
  • Serum Urea < 25 mg/100 ml
  • Absence of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be assessed with the patient before registration
  • Electrocardiogram (ECG) without modifications that suggest a high risk of occurrence of an acute clinical event (such as signs of angina pectoris or high-risk arrhythmia, etc.); cardiologist consultation is required, if relevant abnormalities are observed in the screening ECG-assessment

Who cannot join

  • Prior systemic chemotherapy for any kind of malignancy; prior intravesical chemotherapy or treatment with BCG is allowed
  • Prior radiation of the pelvis or any prior radiation to ≥ 30 % of the bone marrow
  • Evidence of lymph node (N+) or distant metastasis (M1) in the screening imaging assessment, including known brain metastases or leptomeningeal involvement (however, brain-MRI-scans are not required to rule out CNS-involvement, unless there is clinical suspicion of central nervous system (CNS) disease)
  • Any contraindication with regard to contrasted imaging (MRI or CT)
  • Other malignancies except adequately treated basal carcinoma of the skin, localized prostate cancer Gleason ≤ 6, in-situ cervix carcinoma or any other tumor with a disease free interval ≥ 5 years
  • Peripheral neuropathy Grade ≥ 2 NCI CTCAE v4.03 or hearing impairment Grade ≥ 2 NCI CTCAE v.4.03
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  • Any concurrent chronic system immune therapy or previous organ allograft
  • Weight loss > 5 % within the last 3 months before registration
  • Any other serious illness or medical condition including:
  • Infection requiring systemic anti-infective therapy within the last 2 weeks before registration
  • History of cardio-vascular disease that might compromise the safe administration of cisplatin
  • Dehydration requiring IV fluid substitution
  • Any medical condition that might not be controlled, e.g. patients with unstable angina pectoris, myocardial infarction < 6 months before registration or uncontrolled diabetes, congestive cardiac failure > NYHA grade I
  • Known hypersensitivity to the study drugs or to drugs with similar chemical structures
  • Treatment with any potent CYP3A4 inhibitor or inductor (e.g. ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, rifampicine) or phenytoine; replacement of such treatment with alternative treatment options before start of study treatment is acceptable, if medically feasible and ethically acceptable
  • 12. Treatment with any medication that is known to prolong the QT/QTc interval and/or to cause Torsades de Pointes (e.g. azithromycine, amitryptiline, imipramine, clozapine, flu-ox¬etine, cisapride); replacement of such treatment with alter¬na¬ti¬ve options before start of study treatment is acceptable, if medically feasible and ethically acceptable
  • Treatment with hexamethylmelamin, pyridoxine, penicillamine or any other drug with known potential to affect the efficacy of cisplatin
  • Treatment with any other investigational or anti-cancer therapy ≤ 30 days before registration
  • Pregnant or lactating female patients or female patients of childbearing potential with positive pregnancy test at screening
  • Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 6 months after the study
  • Sexually active fertile men, who are unwilling or unable to use an effective birth control from day of informed consent and for up to 6 months after the last cycle of chemotherapy, if their partners are women of child-bearing potential (if cystectomy is not performed) effective birth control means the use of condoms ideally combined with any acceptable contraception of the male patient's partner as described in exclusion criterion 16

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Dept. Urology, University Hospital Marburg

    Marburg/ Lahn, Baldingerstraße, 35033

  • Dept. Urology, University Hospital Tübingen

    Tübingen, Hoppe-Seyler-Straße 3, 72076

Other trials in Germany

About this study

Phase Ib/II study assessing the neo-adjuvant combination therapy of vinflunine with cisplatin followed by radical cystectomy in patients with muscle-invasive bladder cancer (JaNEO).

Conditions
Bladder Cancer
Being tested
Vinflunine, Cisplatin, Radical cystectomy
Keywords
neo-adjuvant, vinflunine, cisplatin, radical cystectomy, muscle-invasive bladder cancer, JaNEO
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VinflunineDrug

    One cycle is defined as a period of 3 weeks of treatment:

    Vinflunine (280 mg/m²) on Day 1, every 21 days as a 20 minute IV infusion

    Cisplatin (70 mg/m²) on Day 2, every 21 days

    4 cycles of neo-adjuvant chemotherapy prior to radical cystectomy

  • CisplatinDrug

    One cycle is defined as a period of 3 weeks of treatment:

    Vinflunine (280 mg/m²) on Day 1, every 21 days as a 20 minute IV infusion

    Cisplatin (70 mg/m²) on Day 2, every 21 days

    4 cycles of neo-adjuvant chemotherapy prior to radical cystectomy

  • Radical cystectomyProcedure or surgery

    max. 4 weeks after 4 cycles of neo-adjuvant treatment radical cystectomy will be performed

Study groups in NCT02845050
Study groupRoleWhat they receive
Vinflunine+Cisplatin+radical cystectomyExperimentalneoadjuvant combination of Vinflunine+Cisplatin before radical cystectomy as proof of principle (one arm only!)
Receives: Drug: Vinflunine; Drug: Cisplatin; Procedure: Radical cystectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Response (pCR)

    Rate of pathological complete response (pCR) at cystectomy assessed by central pathological review (Prof. Hartmann, Erlangen), if the initial safety phase allows continuation of the trial with the phase II part

    Measured: cystectomy

Secondary outcomes (8)

  1. Overall radiological response rate before cystectomy

    RECIST v1.1

    Measured: prior cystectomy

  2. Progression rate

    RECIST v1.1

    Measured: after 2 and 4 cycles (of 21 days length) of treatment

  3. Safety of chemotherapy measured by adverse events and clavien-dindo grades

    An evaluation of adverse events and serious adverse events will be done. Alle analyses of adverse events will be done using the CTCAE-classification v4.03. Events of grade 3-4 will be evaluated seperatly. Also, all events reported to be related to cystectomy will be evaluated using the clavien-dindo-grades.

    Measured: through study completion after 12 months-follow up

  4. Rate of complications at cystectomy

    Measured: at cystectomy

  5. Perioperative morbidity/mortality

    Measured: 30 days and 90 days post surgery

  6. Cancer-specific survival

    Evaluation will be done from date of study registration to death on disease or the last visit date (if not death at timepoint of evaluation). Patients that died due to other reasons than cancer will be evaluated with their last date known alive.

    Measured: one year after cystectomy

  7. QoL - GIQLI

    If Values for total or subscale scores are missing, no imputation will be applied. To summarize scored scales descriptive statistics will be used. Patients with an evaluable baseline score and at least one evaluable post baseline score will be included into analyses to evaluate changes from baseline.

    Measured: Cycle 1-4 Day 1+ cystectomy + 1,3 and 12 months after cystectomy

  8. QoL - QLQ-C30

    If Values for total or subscale scores are missing, no imputation will be applied. To summarize scored scales descriptive statistics will be used. Patients with an evaluable baseline score and at least one evaluable post baseline score will be included into analyses to evaluate changes from baseline.

    Measured: Cycle 1-4 Day 1+ cystectomy + 1,3 and 12 months after cystectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2016 (estimated)
  2. Study startJul 2016 (estimated)
  3. Primary completionJul 2017
  4. Study completionJul 2017

Why it stopped: No participants found

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02845050
Sponsor's protocol ID
JaNEO-001
Other IDs
2016-000081-33, 2016
Acronym
JaNEO
Status last verified
Feb 2018
First submitted
12 Jul 2016
Last updated
13 Feb 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Vinflunine, Cisplatin and Radical cystectomy in people with Bladder Cancer, run by Ligartis GmbH at 2 sites in Germany.

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 16 inclusion and 21 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: withdrawn, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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.

What does the primary outcome measure?

Pathological Complete Response (pCR) (time frame: cystectomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02845050.

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 13 Feb 2018.

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