CompletedPhase 2

caBozantinib in cOllectiNg ductS Renal Cell cArcInoma

Italy23 participantsStarted 2018-01-12

Plain-language summary

This is a single-arm, phase II trial (monocentric) study designed to determine To evaluate activity of Cabozantinib in terms of ORR according to the RECIST 1.1 criteria in Metastatic Collecting Duct Renal Cell Carcinoma

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Written Informed Consent Form
✓. Unresectable, advanced or metastatic collecting ducts carcinoma untreated with any systemic agent for advanced disease
✓. Measurable disease as defined by RECIST v1.1 criteria
✓. Age ≥18 years
✓. ECOG Performance Status 0-1
✓. Any of the following laboratory test findings:
✓. Availability of a representative FFPE tumor specimen collected within 24 months of starting first-line cabozantinib that enables the definitive diagnosis of CDC (the archival specimen must contain adequate viable tumor tissue to enable candidate biomarkers status; the specimen may consist of a tissue block or at least 15 unstained serial sections; for core needle biopsy specimens, at least two cores should be available for evaluation)
✓. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and for 4 months after the last dose of study treatment

Exclusion criteria

✕. Previous therapy for advanced disease; any medical adjuvant treatment must have been stopped at least six months before entry into the study
✕. 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)
✕. Poorly controlled hypertension \[defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg\].
✕. 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
✕. Major surgery or trauma within 28 days before to study entry; the such as catheter placement not considered to be major surgery).
✕. 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.
✕. 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.
✕. Patients with GI disorders associated with a high risk of perforation or fistula formation.

What they're measuring

Objective response rate (ORR)

Timeframe: 30 Month

Trial details

NCT IDNCT03354884

SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-19

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