Status:
TERMINATED
Study of BEZ235 as Monotherapy in Patients With Transitional Cell Carcinoma After Failure of Platinum Based Chemotherapy
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborating Sponsors:
Novartis
Conditions:
Carcinoma Transitional Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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 …)
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01856101
Start Date
February 1 2013
End Date
January 1 2014
Last Update
April 10 2019
Active Locations (12)
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1
Clinique Saint-Pierre à Ottignies
Ottignies, Brabant Wallon, Belgium, 1340
2
Epicura- RHMS Baudour
Baudour, Hainaut, Belgium, 7331
3
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium, 6000
4
Hôpital de Jolimont
Haine-Saint-Paul, Hainaut, Belgium, 7100