caBozantinib in cOllectiNg ductS Renal Cell cArcInoma

NCT03354884 | Completed Phase 2

• 1 other identifier: INT 150/17
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Collecting Duct Carcinoma (Kidney)

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  To evaluate activity of Cabozantinib in terms of ORR according to the RECIST 1.1 criteria.

  30 Month

Secondary Outcomes (3)

• Progression free Survival (PFS)

  30 Month

• Overall survival (OS)

  30 Month

• Safety and Tolerability (Adverse Events)

  30 Month

Study Arms (1)

Cabozantinib

EXPERIMENTAL

All subjects will receive open label Cabozantinib 60 mg orally once daily

Drug: cabozantinib

Interventions

cabozantinib DRUG

cabozantinib 60 mg orally once daily

Cabozantinib

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.
• Subjects with clinically relevant ongoing complications from prior radiation therapy.
• 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.
• 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
• Inability to swallow tablets or capsules.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Giuseppe Procopio

Milan, 20133, Italy

Location

Related Publications (20)

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• Procopio G, Sepe P, Claps M, Buti S, Colecchia M, Giannatempo P, Guadalupi V, Mariani L, Lalli L, Fuca G, de Braud F, Verzoni E. Cabozantinib as First-line Treatment in Patients With Metastatic Collecting Duct Renal Cell Carcinoma: Results of the BONSAI Trial for the Italian Network for Research in Urologic-Oncology (Meet-URO 2 Study). JAMA Oncol. 2022 Jun 1;8(6):910-913. doi: 10.1001/jamaoncol.2022.0238.

  PMID: 35420628 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Giuseppe Procopio, MD

  Fondazione IRCCS Istituto Nazionale Tumori - Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 28, 2017
• Study Start: January 12, 2018
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)