Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354884
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

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


Contacts
Layout table for location contacts
Contact: Giuseppe Procopio, MD +390223904450 giuseppe.procopio@istitutotumori.mi.it
Contact: Rosanna Montone, Dr.ssa +390223903817 rosanna.montone@istitutotumori.mi.it

Locations
Layout table for location information
Italy
Giuseppe Procopio Recruiting
Milan, Italy, 20133
Contact: Giuseppe Procopio, MD    +390223904450    giuseppe.procopio@istitutotumori.mi.it   
Contact: Rosanna Montone, dr.ssa    +390223903817    rosanna.montone@istitutotumori.mi.it   
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
Layout table for investigator information
Principal Investigator: Giuseppe Procopio, MD Fondazione IRCCS Istituto Nazionale Tumori - Milano
Publications:

Layout table for additonal information
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: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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