Advanced renal cancer MedDRA version: 12.1 Level: LLT Classification code 10038390 Term: Renal cancer recurrent
Conditions
Interventions
Trade Name: Torisel
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TEMSIROLIMUS
CAS Number: 162635-04-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Hellenic Cooperative Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients (18th year of age completed). Signed and dated written informed consent form prior to any procedures related to this protocol. Histologically confirmed advanced clear cell renal cancer. Measurable disease. Failure of first line treatment of the combination bevacizumab and interferon A2 alpha. Performace status 0-2, according to ECOG. Satisfactory hematological parameters: WBC >4000mm3 PLT >100000/mm3 ANC>1200/mm3 Hemoglobin>9,0 g/dL (can be achieved with red blood cell transfusion) Satisfactory biochemical parameters: Serum creatinine=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior treatment with mTOR inhibitor and/or TKI. Major surgery (including open biopsy) or insufficient recovery or existence of major trauma within 4 weeks before enrollment. Uncontrolled hypertension. Active infection requiring systemic treatment within 4 weeks prior to enrollment. Minor surgery (e.g. catheter replacement) within 2 days before enrollment. Scheduled major surgery within the treatment period. Medical history in the last 6 months prior to enrollment of significant cardiovascular disease, diabetes, cardiac infarction, unstable angina, uncontrolled arrhythmia or significant heart failure. Indications of uncontrolled metastases or disease progression in CNS lesions (the suspicion of uncontrolled metastases or disease progression should be eliminated by imaging techniques within 14 days prior to enrollment). Medical history in the last 5 years prior to enrollment of any other malignancies (excluding the basal or squamous skin cell carcinoma or in situ carcinoma of the cervix). History of non-healing wound including active gastric ulcer. History of fistula in the last 6 months prior to enrollment. History of gastrointestinal perforation. Patient incapacity (for psychiatric or social reasons) to conform to the protocol. History of hemorrhagic predisposition. History of hypersensitivity to the medications under investigation. Significant proteinuria. Prior immunotherapy within 4 weeks prior to enrollment. Prior radiation treatment within 2 weeks prior to enrollment. Concomitant medication with inducers or strong inhibitors of the coenzyme CYP3A4. Concurrent participation in other interventional clinical trials with IMPs. History of chronic interstitial lung disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy (6 month PFS);Secondary Objective: Progression Free Survival (PFS) Overall Survival (OS) Response Rate (RR) Tumor shrinkage Evaluation of safety Adverse events with any causal relationship with the study IMPs Serious adverse events with any causal relationship with the study IMPs Quality of Life (QoL) evaluation using the QLQ C-30 questionnaire Exploration of antiangiogenic parameters for response ;Primary end point(s): Evaluation of efficacy (6 month PFS) | — |
Countries
Greece
Outcome results
None listed