Cabozantinib in Patients With Advanced Penile Squamous Cell Carcinoma (PSCC) (CaboPen) (CaboPen)

February 24, 2021 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Cabozantinib in Patients With Advanced Penile Squamous Cell Carcinoma (PSCC): an Open-label, Single-center, Phase 2, Single-arm Trial (CaboPen)

Cabozantinib in patients with advanced penile squamous cell carcinoma (PSCC): an open-label, single-center, phase 2, single-arm trial (CaboPen)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

an open-label, single-center, phase 2, single-arm trial

Study Type

Interventional

Enrollment (Anticipated)

37

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

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Age 18-75
  2. Written informed consent
  3. ECOG (Eastern Cooperative Oncology Group) performance status 0-1
  4. Cytologically or histologically proven diagnosis of PSCC.
  5. Histologically (Tru-cut biopsy) proven diagnosis of loco-regional nodal disease will be required in all cases except for those with clinical contraindications.
  6. Uni- or bidimensionally measurable disease as defined by RECIST v1.1 criteria.
  7. Clinical stage N2-3 and/or M1 (TNM 2002).
  8. Locoregional relapse after prior major surgery/ies (either single or multiple).
  9. No prior systemic therapy except for the administration of VBM (Vinblastine, Bleomycin, Methotrexate) chemotherapy for superficial disease if administered at least 6 months prior to study enrolment.
  10. Adequate organ and marrow function .
  11. Patients must be accessible for treatment and follow up as well as they must be willing and capable to comply with the requirements of the study. Patients registered on this trial must be treated and followed at the study sponsor site.

Exclusion Criteria:

  1. 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 by-pass graft surgery.
    • Symptomatic peripheral vascular disease.
    • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
    • Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted during the study but should be used with caution - please refer to the study drug IB).
    • Screening ECG with a QTc>450 msec, congenital long QT syndrome, history of sustained ventricular tachycardia, history of ventricular fibrillation or torsade de pointes, bradycardia defined as heart rate < 50 bpm (patients with a pacemaker and heart rate > 50 bpm are eligible).
    • Uncontrolled hypertension.
  2. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months ior to first dose of study drug.
  3. History of HIV infection or active chronic hepatitis B or C.
  4. Active clinically serious infections (> grade 2 NCI-CTC version 5.0).
  5. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics).
  6. Patients undergoing renal dialysis
  7. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT treated basal cell carcinoma or any cancer curatively treated > 5 years prior to study entry.
  8. History of clinically-significant gastrointestinal bleeding, inflammatory bowel disease, and other GI disorders associated with high risk of perforation or fistula formation or any other condition.
  9. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
  10. Major surgery within 12 weeks before the first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment. Minor surgery (including uncomplicated tooth extractions) within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
  11. History of allogenic organ solid transplantation.
  12. Fertile males not willing to use a highly effective method of contraception or whose female partner is not using a highly effective contraception protection.
  13. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  14. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
  15. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug.
  16. Hemoptysis >=2.5 ml red blood within 3 months before treatment, signs indicative of pulmonary hemorrhage, cavitating pulmonary lesion, tumor invading major blood vessels and/or GI tract, endotracheal or endobronchial tumors History of clinically-significant gastrointestinal bleeding, inflammatory bowel disease, or any other condition among those listed in the full protocol.
  17. Patients unable to swallow oral medications.
  18. Concomitant anticoagulation with oral anticoagulants or platelet inhibitors.
  19. History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.

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
Cabozantinib will be administered orally at a dose of 60 mg/day continuously until 28 days prior to planned surgery or at time of the evidence of disease progression or onset of unacceptable toxicity.
Drug: Cabozantinib
Cabozantinib 60 mg/day orally
Other Names:
  • CABOMETYX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response -rate by RECIST v1.1 criteria
Time Frame: 40 months
Assessment of response-rate by RECIST v1.1. Complete response + partial response
40 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-Emergent Adverse Event(safety and tolerability)
Time Frame: 40 months
Assessment of the safety and tolerability: incidence, nature and severity of treatment-related adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
40 months
Pathologic complete response (pCR)
Time Frame: 40 months
Histological report of radical surgery
40 months
Progression-free survival (PFS).
Time Frame: 40 months
Recist 1.1 criteria
40 months
Overall Survival (OS).
Time Frame: 40 months
time will be calculated as the interval from treatment start date to the date of death for any cause, with censoring at the date of last contact for patients alive.
40 months
Variations of the Quality of Life
Time Frame: 40 months

Variations of the Quality of Life score as assessed with the Edmonton Symptom Assessment Scale (ESAS), validated in Italian language. In this quality of life there are specify 9 main symptons: the score range is from 0 to 10 for each one.

For each symptom the "0 score" corrisponds to "no symptom present" (better outcome) and the "10 score" corrisponds to "maximum symptom assessable" (worse outcome). The listed symptoms are: 1) Pain 2) Fatigue 3) Nausea 4) Depression 5) Anxiety 6) Somnolence 7) Loss of appetite 8) General Malaise 9) Dispnea. The total score is ranging from 0 to 90
40 months
FDG-PET/CT response rate according to EORTC criteria
Time Frame: 40 months

  1. to determine the rate of concordance with CT scan RECIST 1.1 response criteria and PET/CT EORTC Criteria

    • Complete response: complete disappearance of all target lesions with the exception of nodal disease (RECIST 1.1) and Complete resolution of FDG uptake in all lesions (EORTC)
    • Partial response (PR): greater than or equal to 30% decrease under baseline of the sum of target lesions (RECIST 1.1) and ≥ 25% reduction in the sum of SUVmax
    • Stable disease (SD): Not qualify for CR, PR or PD
    • Objective Progression (PD): 20% increase in the sum of diameters of target lesions or appearance of new unequivocal malignant lesions (RECIST 1.1) and ≥ 25% Increase in the sum of SUVmax or appearance of new lesions.
  2. To evaluate the relationship existing between tumor response measured by FDG-PET/CT EORTC Criteria (mainly early PET response as evaluated at first restaging) and pCR-rate (pT0 after surgery) and progression-free survival (months).
40 months

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

  • Study Chair: Daniele Raggi, MD, Fondazione IRCCS Istituto Nazionale Tumori

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)

August 1, 2019

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (ACTUAL)

May 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CaboPen

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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