caBozantinib in cOllectiNg ductS Renal Cell cArcInoma (BONSAI)

May 7, 2021 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

caBozantinib in cOllectiNg ductS Renal Cell cArcInoma (BONSAI)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single-arm, phase II trial (monocentric)

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20133
        • Giuseppe Procopio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 30 Month
To evaluate activity of Cabozantinib in terms of ORR according to the RECIST 1.1 criteria.
30 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free Survival (PFS)
Time Frame: 30 Month
To evaluate activity of Cabozantinib in terms of PFS
30 Month
Overall survival (OS)
Time Frame: 30 Month
To evaluate activity of Cabozantinib in terms of OS
30 Month
Safety and Tolerability (Adverse Events)
Time Frame: 30 Month
To evaluate tolerability of Cabozantinibv during the treatment in particular the Adverse Events
30 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

  • Principal Investigator: Giuseppe Procopio, MD, Fondazione IRCCS Istituto Nazionale Tumori - Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 12, 2018

Primary Completion (ACTUAL)

November 19, 2020

Study Completion (ACTUAL)

November 19, 2020

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (ACTUAL)

November 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT 150/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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