Collecting Duct Renal Cell Carcinoma MedDRA version: 21.0 Level: LLT Classification code 10073252 Term: Carcinoma of the collecting ducts of Bellini System Organ Class: 100000004864
Conditions
Interventions
Trade Name: CABOMETYX
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Cabozantinib
CAS Number: 1140909-48-3
Current Sponsor code: XL184, EXEL-7184, EXEL-02977184
Concentration unit: mg mi
Sponsors
FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written Informed Consent Form 2.Unresectable, advanced or metastatic collecting ducts carcinoma untreated with any systemic agent for advanced disease 3.Measurable disease as defined by RECIST v1.1 criteria 4.Age =18 years 5.ECOG Performance Status 0-1 6.Any of the following laboratory test findings: -Hemoglobin > 9 g/dL (5.6 mmol/L) -WBC > 2,000/mm3 -Neutrophils > 1,500/mm3 -Platelets > 100,000/mm3 -AST or ALT =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1.Previous therapy for advanced disease; any medical adjuvant treatment must have been stopped at least six months before entry into the study 2.History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) 3.Poorly controlled hypertension [defined as systolic blood pressure (SBP) of =140 mmHg or diastolic blood pressure (DBP) of = 90mmHg]. 4.History of cerebrovascular accidents, including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible 5.Major surgery or trauma within 28 days before to study entry; the presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery). 6.Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before randomization. 7.Evidence of active bleeding or bleeding diathesis and/or clinically-significant GI bleeding within 6 months before the first dose of study treatment; 3 months for pulmonary hemorrhage and patients with tumor invading or encasing any major blood vessels. 8.Patients with GI disorders associated with a high risk of perforation or fistula formation. 9.Subjects with clinically relevant ongoing complications from prior radiation therapy. 10.Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures. 11.Previous or ongoing treatment (except for adjuvant therapies) with any of the following anti-cancer therapies: chemotherapy, immunotherapy, target therapies, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of Cabozantinib 12.Inability to swallow tablets or capsules.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate activity of Cabozantinib in terms of ORR according to the RECIST 1.1 criteria.;Secondary Objective: - To evaluate PFS and OS; - To evaluate tolerability of Cabozantinib. ;Primary end point(s): Objective response rate (ORR) ;Timepoint(s) of evaluation of this end point: Duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival (PFS); Overall survival (OS); Tolerability of cabozantinib; Exploratory objectives of this study: ¿to identify the somatic mutation profiles in CDC on disease associated targets by NGS; ¿to identify transcript fusions of selected genes by performing a RNA sequencing; ¿to monitor the immunological properties of tumor cells and the state of circulating immune cells, to assess the modulating activity of cabozantinib on local and systemic tumor immunity. ;Timepoint(s) of evaluation of this end point: Duration of the study; Duration of the study; Duration of the study; Duration of the study | — |
Countries
Italy
Contacts
Public ContactClinical Trial Center
Fondazione IRCCS Istituto Nazionale dei Tumori
Outcome results
None listed