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Carcinoma Transitional CellPhase 2BEZ235NCT01856101

Study of BEZ235 as Monotherapy in Patients With Transitional Cell Carcinoma After Failure of Platinum Based Chemotherapy

A Phase 2 study testing BEZ235 in people with Carcinoma Transitional Cell, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 12 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The mTOR (mammalian Target of Rapamycin) protein is the center of the mTOR pathway that plays an important role in cell growth, proliferation, survival and angiogenesis through sensing and integrating energetic signals from cellular environment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma Transitional Cell
What is being tested?
BEZ235
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
12 sitesin 2 countries
Study dates
Feb 2013to Jan 2014
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically- or cytologically-confirmed locally advanced or metastatic TCC not amenable to curative surgery or radiation.
  • Documented disease progression (according RECIST 1.1 criteria) after first line platinum-based therapy (given in neoadjuvant/adjuvant or palliative setting).
  • An interval of >4 weeks since last anticancer treatment.
  • Archival paraffin-embedded tumor tissue (block or at least 20 unstained slides) of the primary tumor and/or metastases. The most recent archival tissue is mandatory. Recidive of the disease should lead to perform if possible novel biopsies, as major oncogenic differences are found between primary tumor and secondary lesions.
  • At least one measurable lesion by MRI or CT-scan
  • ECOG performance status 0-1, in stable medical condition
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  • Patients must have adequate organ function: Hemoglobin ≥ 9 g/100 ml, neutrophils ≥ 1,000/mm3, platelets ≥ 100,000/mm, INR ≤ 1.5, total serum bilirubin ≤ 1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (or <5.0 x ULN if hepatic metastases are present), creatinine £1.5 x ULN, fasting plasma glucose <140mg/dl, HbA1c < 8%.
  • Patients must be over 18 years old and able to give written informed consent.
  • Signed informed consent prior to beginning protocol specific procedure

Who cannot join

  • Non- TCC bladder cancer
  • More than 2 prior chemotherapy regimens given for palliation.
  • Concurrent malignancy or previous malignancy in the last 3 years prior to start the study treatment (with the exception of a history of adequately treated cervical carcinoma in situ or non-melanoma skin cancer)
  • Patient with active uncontrolled or symptomatic central nervous system (CNS metastases).
  • Significant active cardiac disease including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias.
  • Other uncontrolled medical condition (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …)
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  • Other concomitant anticancer therapy.
  • Previous therapy with PI3K and/or mTOR inhibitors (sirolimus, temsirolimus, everolimus)
  • Concomitant drugs such as coumarin and warfarin, and drugs known to induce torsade de pointe, drugs known to be moderate or strong inhibitors or inducers of CYP3A4
  • Pregnancy or risk of pregnancy.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Belgium11 sites

  • Clinique du Sud Luxembourg

    Arlon, Luxembourg, 6700

  • Epicura- RHMS Baudour

    Baudour, Hainaut, 7331

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

  • Grand Hôpital de Charleroi

    Charleroi, Hainaut, 6000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Hôpital de Jolimont

    Haine-Saint-Paul, Hainaut, 7100

  • CHU de Liège site du Sart Tilman

    Liège, Liège, 4000

  • Clinique et Maternité Ste Elisabeth

    Namur, 5000

  • Clinique Saint-Pierre à Ottignies

    Ottignies, Brabant Wallon, 1340

  • Centre Hospitalier Wallonie Picarde

    Tournai, Hainaut, 7500

  • CHU de Mont-Godinne

    Yvoir, Namur, 5530

Other trials in Belgium

Luxembourg1 site

  • Centre Hospitalier de Luxembourg

    Luxembourg, Grand-Duché de Luxembourg, 1210

Other trials in Luxembourg

About this study

Official title: A Single Arm, Multicenter, Phase II Study of BEZ235 as Monotherapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) After Failure of Platinum Based Chemotherapy.

The mTOR (mammalian Target of Rapamycin) protein is the center of the mTOR pathway that plays an important role in cell growth, proliferation, survival and angiogenesis through sensing and integrating energetic signals from cellular environment. The mTOR protein is composed of two complex, mTOR complex 1 (mTOR C1) and mTOR complex 2 (mTOR C2).

In regards of mTOR pathway dysregulations observed in TCC development, there is a rational to test BEZ23 in advanced TCC. BEZ235 is a pan-class I PI3K inhibitor that, in addition, binds to the catalytic site of mTOR, inhibiting mTOR C1 and mTOR C2.

Being tested
BEZ235
Keywords
TCC, Failure of platinum based chemotherapy
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

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

  • BEZ235Drug

    Also called BEZ235 is a potent dual pan class I PI3K and mTOR inhibitor.

    The investigational study drug used in this trial is BEZ235, supplied as 200 mg, 300 mg and 400 mg sachets. BEZ235 is administered continuously twice-daily; complete cycle is 28 days. Starting dose is 300mg PO bid. At cycle 1 day 15, based on a clinical assessment, dose is adjusted for the rest of the study:• If no adverse event (AE) or only mild AE (G1) : the dose will be increase to 400 mg bid• If AE = G2 : the patient will continue at 300 mg bid • If G3 AE or higher : BEZ235 will be interrupt until resolved to ≤ G1 then reduce dose to 200 mg bid

Study groups in NCT01856101
Study groupRoleWhat they receive
BEZ235, powderExperimental* Group 1: patients without PI3K pathway activation; no loss of PTEN and no activating PIK3CA mutation. * Group 2: patients with PI3K pathway activation as defined by PIK3CA mutation and/or PTEN loss
Receives: Drug: BEZ235

What is being measured

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

  1. Determine the efficacy of BEZ235 in patients with palliative TCC

    • Control disease rate at 16 weeks, including complete responses, partial responses and stable diseases according to RECIST criteria.

    Measured: at 16 weeks (radiological evaluation every 8 weeks)

Secondary outcomes (1)

  1. Determine the safety profile of BEZ235 in patients with advanced TCC

    The patient will have an appointment with the investigator on day 15 of cycle 1 and every day 1 of each cycle.

    Measured: participants will be followed for the duration of hospital stay, an expected average of 16 weeks

Timeline

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

  1. First posted17 May 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionJan 2014
  4. Study completionJan 2014

Why it stopped: Novartis decided to stop the marketing of BEZ235

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01856101
Sponsor's protocol ID
UCL-ONCO2012-01
Other IDs
2012-004123-20, CBEZ235ZBE01T
Acronym
BEZ235
Status last verified
Apr 2019
First submitted
10 Dec 2012
Last updated
10 Apr 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BEZ235 in people with Carcinoma Transitional Cell, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 12 sites in 2 countries.

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 9 inclusion and 10 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 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Belgium, Luxembourg. 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 phase mean?

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 stopped early (reason given: Novartis decided to stop the marketing of BEZ235). 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.

What does the primary outcome measure?

Determine the efficacy of BEZ235 in patients with palliative TCC (time frame: at 16 weeks (radiological evaluation every 8 weeks)). 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 NCT01856101.

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 10 Apr 2019.

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