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caBozantinib in cOllectiNg ductS Renal Cell cArcInoma (BONSAI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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

Condition or disease Intervention/treatment Phase
Collecting Duct Carcinoma (Kidney) Drug: cabozantinib Phase 2

Detailed Description:
This is a single-arm, phase II trial (monocentric)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: caBozantinib in cOllectiNg ductS Renal Cell cArcInoma (BONSAI)
Actual Study Start Date : January 12, 2018
Actual Primary Completion Date : November 19, 2020
Actual Study Completion Date : November 19, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cabozantinib
All subjects will receive open label Cabozantinib 60 mg orally once daily
 Drug: cabozantinib
cabozantinib 60 mg orally once daily


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 30 Month ]
    To evaluate activity of Cabozantinib in terms of ORR according to the RECIST 1.1 criteria.


Secondary Outcome Measures :
  1. Progression free Survival (PFS) [ Time Frame: 30 Month ]
    To evaluate activity of Cabozantinib in terms of PFS

  2. Overall survival (OS) [ Time Frame: 30 Month ]
    To evaluate activity of Cabozantinib in terms of OS

  3. Safety and Tolerability (Adverse Events) [ Time Frame: 30 Month ]
    To evaluate tolerability of Cabozantinibv during the treatment in particular the Adverse Events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 < 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354884


Locations
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Italy
Giuseppe Procopio
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: Giuseppe Procopio, MD Fondazione IRCCS Istituto Nazionale Tumori - Milano
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT03354884    
Other Study ID Numbers: INT 150/17
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Ductal, Lobular, and Medullary