Metastatic renal cell carcinoma MedDRA version: 21.1 Level: LLT Classification code 10050076 Term: Metastatic renal carcinoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: CABOMETYX
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CABOZANTINIB
Current Sponsor code: CABOZANTINIB 60
Ot
Sponsors
Spanish Oncology Genitourinary Group - SOGUG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Documented histological or cytological diagnosis of renal cell cancer. 2. Measurable disease per RECIST 1.1 as determined by the investigator. 3. Metastatic disease. 4. Patient must have signed the informed consent document. 5. Capable of understanding and complying with the protocol requirements. 6. ECOG-PS 0-2. 7. Patients aged >70 years old with SIOG (Society of Geriatric Oncology) defined fragile population or patients >75 years with or without SIOG defined fragility. 8. No previous treatment for mRCC. 9. Adequate organ function based on standard laboratory tests including haematology, serum chemistry, lipids, coagulation, thyroid function, and urinalysis. a. Absolute neutrophil count (ANC) = 1500/mm3. b. Platelets = 100,000/mm3. c. Hemoglobin = 9 g/dL (= 90 g/L). d. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Previous treatment for mRCC. 2. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before inclusion. 3. Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 3 months before inclusion. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of inclusion. 4. Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel). Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin ( 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment. iii. Stroke (including TIA), myocardial infarction, or other ischemic event, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 6 months before inclusion. b. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: i. Tumors invading the GI-tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction. ii. Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before inclusion. Note: Complete healing of an intra-abdominal abscess must be confirmed before inclusion. c. Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 3 months before inclusion. d. Cavitating pulmonary lesion(s) or known endobronchial disease manifestation. e. Lesions invading major pulmonary blood vessels. f. Other clinically significant disorders such as: i. Active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)- related illness, or chronic hepatitis B or C infection. ii. Serious non-healing wound/ulcer/bone fracture. iii. Malabsorption syndrome. iv. Uncompensated/symptomatic hypothyroidism. v. Moderate to severe hepatic impairment (Child-Pugh B or C). vi. Requirement for hemodialysis or peritoneal dialysi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cabozantinib efficacy (Objective Response Rate (ORR) as evaluated by RECIST 1.1 criteria) in previously untreated aged population with metastatic renal cell carcinoma (mRCC).; Secondary Objective: Cabozantinib safety profile and tolerability according to NCI-CTC v 5.0 criteria Cabozantinib efficacy according to: - Disease Control Rate (DCR) - Progression Free Survival (PFS) - Overall Survival (OS) Correlation between study outcomes (safety and efficacy) and functionality, comorbidity and cognitive and social status in previously untreated aged population with metastatic renal cell carcinoma ;Primary end point(s): Objective Response Rate (ORR);Timepoint(s) of evaluation of this end point: Complete Response (CR) + Partial Response (PR) evaluated by RECIST 1.1 according to investigator criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety. - Disease Control Rate (DCR). - Progression Free Survival (PFS) - Overall Survival (OS). - Correlation between study outcomes and functionality, comorbidity and cognitive and social status in previously untreated aged population with metastatic renal cell carcinoma will be evaluated. ; Timepoint(s) of evaluation of this end point: - Safety profile assessed according to NCI-CTC v 5.0 criteria will be the number of patients experiencing AE. - Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated by RECIST 1.1 criteria according to investigator criteria. - Time in months since the patient’s study enrolment until patient progression according to RECIST 1.1 criteria. - Time in months since the patient’s study enrolment until death. | — |
Countries
Spain
Contacts
Public ContactCLINICAL OPERATIONS DEPARTMENT
APICES SOLUCIONES S.L
Outcome results
None listed