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caBozantinib in cOllectiNg ductS Renal Cell cArcInoma (BONSAI)

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ClinicalTrials.gov Identifier: NCT03354884
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Tracking Information
First Submitted Date  ICMJE November 21, 2017
First Posted Date  ICMJE November 28, 2017
Last Update Posted Date May 10, 2021
Actual Study Start Date  ICMJE January 12, 2018
Actual Primary Completion Date November 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2017)		 Objective response rate (ORR) [ Time Frame: 30 Month ]
To evaluate activity of Cabozantinib in terms of ORR according to the RECIST 1.1 criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
  • Progression free Survival (PFS) [ Time Frame: 30 Month ]
    To evaluate activity of Cabozantinib in terms of PFS
  • Overall survival (OS) [ Time Frame: 30 Month ]
    To evaluate activity of Cabozantinib in terms of OS
  • Safety and Tolerability (Adverse Events) [ Time Frame: 30 Month ]
    To evaluate tolerability of Cabozantinibv during the treatment in particular the Adverse Events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE caBozantinib in cOllectiNg ductS Renal Cell cArcInoma
Official Title  ICMJE caBozantinib in cOllectiNg ductS Renal Cell cArcInoma (BONSAI)
Brief 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
Detailed Description This is a single-arm, phase II trial (monocentric)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Collecting Duct Carcinoma (Kidney)
Intervention  ICMJE Drug: cabozantinib
cabozantinib 60 mg orally once daily
Study Arms  ICMJE Experimental: Cabozantinib
All subjects will receive open label Cabozantinib 60 mg orally once daily
Intervention: Drug: cabozantinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2017)		 23
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 19, 2020
Actual Primary Completion Date November 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 < 3 x ULN (< 5 x ULN if liver metastases are present)
    • Total Bilirubin < 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
    • Serum creatinine < 1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 40 mL/min (measured or calculated by Cockroft-Gault formula)
    • Lipase < 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis
    • PT-INR/PTT ≤ 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care
  7. 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)
  8. 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
  9. Female subjects of childbearing potential must not be pregnant at screening

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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03354884
Other Study ID Numbers  ICMJE INT 150/17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giuseppe Procopio, MD Fondazione IRCCS Istituto Nazionale Tumori - Milano
PRS Account Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP