Clinical trial for the patients who had a locally advanced or metastatictransitional cell carcinoma previously treated by platinum basedchemotherapy.
- Conditions
- To treat patients with histollogically- or cytologically-confirmed locally advanced or metastatic TCC not amenable to curative surgery or radiation.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004123-20-BE
- Lead Sponsor
- Centre du Cancer, Cliniques universitaires Saint-Luc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 38
1. Patients with histollogically- or cytologically-confirmed locally
advanced or metastatic TCC not amenable to curative surgery or
radiation.
2. Documented disease progression (according RECIST 1.1 criteria) after first line platinum-based therapy (given in neoadjuvant/adjuvant or palliative setting).
3. An interval of >4 weeks since last anticancer treatment. 4. 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.
5. At least one measurable lesion by MRI or CT-scan.
6. ECOG performance status 0-1, in stable medical condition.
7. 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%.
8. Patients must be over 18 years old and able to give written informed consent.
9. Signed informed consent prior to beginning protocol specific
procedure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
;
1. Patients with histollogically- or cytologically-confirmed locally
advanced or metastatic TCC not amenable to curative surgery or
radiation.
2. Documented disease progression (according RECIST 1.1 criteria) after first line platinum-based therapy (given in neoadjuvant/adjuvant or palliative setting).
3. An interval of >4 weeks since last anticancer treatment. 4. 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.
5. At least one measurable lesion by MRI or CT-scan.
6. ECOG performance status 0-1, in stable medical condition.
7. 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%.
8. Patients must be over 18 years old and able to give written informed consent.
9. Signed informed consent prior to beginning protocol specific
procedure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
;
1. Patients with histollogically- or cytologically-confirmed locally
advanced or metastatic TCC not amenable to curative surgery or
radiation.
2. Documented disease progression (according RECIST 1.1 criteria) after first line platinum-based therapy (given in neoadjuvant/adjuvant or palliative setting).
3. An interval of >4 weeks since last anticancer treatment. 4. 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.
5. At least one measurable lesion by MRI or CT-scan.
6. ECOG performance status 0-1, in stable medical condition.
7. 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%.
8. Patients must be over 18 years old and able to give written informed consent.
9. Signed informed consent prior to beginning protocol specific
procedure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
1. Non- TCC bladder cancer.
2. More than 2 prior chemotherapy regimens given for palliation.
3. 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).
4. Patient with active uncontrolled or symptomatic central nervous
system (CNS metastases).
5. 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.
6. Other uncontrolled medical condition (active infections requiring
antibiotics, bleeding disorders, uncontrolled diabetes..).
7. Other concomitant anticancer therapy.
8. Previous therapy with PI3K and/or mTOR inhibitors (sirolimus,
temsirolimus, everolimus).
9. Concomittant 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.
10. Pregnancy or risk of pregnancy.
;
1. Non- TCC bladder cancer.
2. More than 2 prior chemotherapy regimens given for palliation.
3. 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).
4. Patient with active uncontrolled or symptomatic central nervous
system (CNS metastases).
5. 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.
6. Other uncontrolled medical condition (active infections requiring
antibiotics, bleeding disorders, uncontrolled diabetes..).
7. Other concomitant anticancer therapy.
8. Previous therapy with PI3K and/or mTOR inhibitors (sirolimus,
temsirolimus, everolimus).
9. Concomittant 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.
10. Pregnancy or risk of pregnancy.
;
1. Non- TCC bladder cancer.
2. More than 2 prior chemotherapy regimens given for palliation.
3. 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).
4. Patient with active uncontrolled or symptomatic central nervous
system (CNS metastases).
5. 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.
6. Other uncontrolled medical condition (active infections requiring
antibiotics, bleeding disorders, uncontrolled diabetes..).
7. Other concomitant anticancer therapy.
8. Previous therapy with PI3K and/or mTOR inhibitors (sirolimus,
temsirolimus, everolimus).
9. Concomittant 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.
10. Pregnancy or risk of pregnancy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method