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Penile Squamous Cell CarcinomaPhase 2CaboPenNCT03943602

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

A Phase 2 study testing Cabozantinib in people with Penile Squamous Cell Carcinoma, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Penile Squamous Cell Carcinoma
What is being tested?
Cabozantinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteItaly
Study dates
1 Aug 2019to 1 Sep 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75
  • Written informed consent
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-1
  • Cytologically or histologically proven diagnosis of PSCC.
  • Histologically (Tru-cut biopsy) proven diagnosis of loco-regional nodal disease will be required in all cases except for those with clinical contraindications.
  • Uni- or bidimensionally measurable disease as defined by RECIST v1.1 criteria.
Show all 11Show fewer
  • Clinical stage N2-3 and/or M1 (TNM 2002).
  • Locoregional relapse after prior major surgery/ies (either single or multiple).
  • 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.
  • Adequate organ and marrow function .
  • 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.

Who cannot join

  • 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.
Show all 28Show fewer
  • 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.
  • 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.
  • History of HIV infection or active chronic hepatitis B or C.
  • Active clinically serious infections (> grade 2 NCI-CTC version 5.0).
  • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics).
  • Patients undergoing renal dialysis
  • 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.
  • 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.
  • Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
  • 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.
  • History of allogenic organ solid transplantation.
  • Fertile males not willing to use a highly effective method of contraception or whose female partner is not using a highly effective contraception protection.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug.
  • 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.
  • Patients unable to swallow oral medications.
  • Concomitant anticoagulation with oral anticoagulants or platelet inhibitors.
  • History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.

Trial locations and contacts

1 site in 1 country.

Daniele Raggi, MD contact

+390223902402

daniele.raggi@istitutotumori.mi.it

Michela Rizzuti, Dr.ssa contact

+390223903067

michela.rizzuti@istitutotumori.mi.it

Italy1 site, 1 recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Daniela Raggi, MD, +390223902402, daniele.raggi@istitutotumori.mi.it

    Recruiting

Other trials in Italy

About this study

Official title: 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)

Read the detailed description

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

Being tested
Cabozantinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CabozantinibDrug

    Also called CABOMETYX

    Cabozantinib 60 mg/day orally

Study groups in NCT03943602
Study groupRoleWhat they receive
CabozantinibExperimentalCabozantinib 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.
Receives: Drug: Cabozantinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. response -rate by RECIST v1.1 criteria

    Assessment of response-rate by RECIST v1.1. Complete response + partial response

    Measured: 40 months

Secondary outcomes (6)

  1. Incidence of treatment-Emergent Adverse Event(safety and tolerability)

    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.

    Measured: 40 months

  2. Pathologic complete response (pCR)

    Histological report of radical surgery

    Measured: 40 months

  3. Progression-free survival (PFS).

    Recist 1.1 criteria

    Measured: 40 months

  4. Overall Survival (OS).

    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.

    Measured: 40 months

  5. Variations of the Quality of Life

    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

    Measured: 40 months

  6. FDG-PET/CT response rate according to EORTC criteria

    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.
    1. 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).

    Measured: 40 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2019
  2. Study start1 Aug 2019
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion1 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03943602
Sponsor's protocol ID
CaboPen
Acronym
CaboPen
Status last verified
Feb 2021
First submitted
26 Mar 2019
Last updated
25 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.

    PubMed 22237781

  • Barnholtz-Sloan JS, Maldonado JL, Pow-sang J, Giuliano AR. Incidence trends in primary malignant penile cancer. Urol Oncol. 2007 Sep-Oct;25(5):361-7. doi: 10.1016/j.urolonc.2006.08.029.

    PubMed 17826651

  • Ornellas AA. Management of penile cancer. J Surg Oncol. 2008 Mar 1;97(3):199-200. doi: 10.1002/jso.20893. No abstract available.

    PubMed 17918225

  • Misra S, Chaturvedi A, Misra NC. Penile carcinoma: a challenge for the developing world. Lancet Oncol. 2004 Apr;5(4):240-7. doi: 10.1016/S1470-2045(04)01427-5.

    PubMed 15050955

  • Heideman DA, Waterboer T, Pawlita M, Delis-van Diemen P, Nindl I, Leijte JA, Bonfrer JM, Horenblas S, Meijer CJ, Snijders PJ. Human papillomavirus-16 is the predominant type etiologically involved in penile squamous cell carcinoma. J Clin Oncol. 2007 Oct 10;25(29):4550-6. doi: 10.1200/JCO.2007.12.3182.

    PubMed 17925550

  • Li D, Han Z, Liu J, Zhang X, Ren J, Yan L, Liu H, Xu Z. Upregulation of nucleus HDGF predicts poor prognostic outcome in patients with penile squamous cell carcinoma bypass VEGF-A and Ki-67. Med Oncol. 2013 Dec;30(4):702. doi: 10.1007/s12032-013-0702-9. Epub 2013 Sep 3.

    PubMed 23999841

  • Zhu Y, Li H, Yao XD, Zhang SL, Zhang HL, Shi GH, Yang LF, Yang ZY, Wang CF, Ye DW. Feasibility and activity of sorafenib and sunitinib in advanced penile cancer: a preliminary report. Urol Int. 2010;85(3):334-40. doi: 10.1159/000315432. Epub 2010 Oct 27.

    PubMed 20980789

  • Bleeker MC, Heideman DA, Snijders PJ, Horenblas S, Dillner J, Meijer CJ. Penile cancer: epidemiology, pathogenesis and prevention. World J Urol. 2009 Apr;27(2):141-50. doi: 10.1007/s00345-008-0302-z. Epub 2008 Jul 8.

    PubMed 18607597

  • Bezerra AL, Lopes A, Santiago GH, Ribeiro KC, Latorre MR, Villa LL. Human papillomavirus as a prognostic factor in carcinoma of the penis: analysis of 82 patients treated with amputation and bilateral lymphadenectomy. Cancer. 2001 Jun 15;91(12):2315-21.

    PubMed 11413520

  • Backes DM, Kurman RJ, Pimenta JM, Smith JS. Systematic review of human papillomavirus prevalence in invasive penile cancer. Cancer Causes Control. 2009 May;20(4):449-57. doi: 10.1007/s10552-008-9276-9. Epub 2008 Dec 11.

    PubMed 19082746

  • Gregoire L, Cubilla AL, Reuter VE, Haas GP, Lancaster WD. Preferential association of human papillomavirus with high-grade histologic variants of penile-invasive squamous cell carcinoma. J Natl Cancer Inst. 1995 Nov 15;87(22):1705-9. doi: 10.1093/jnci/87.22.1705.

    PubMed 7473819

  • Miralles-Guri C, Bruni L, Cubilla AL, Castellsague X, Bosch FX, de Sanjose S. Human papillomavirus prevalence and type distribution in penile carcinoma. J Clin Pathol. 2009 Oct;62(10):870-8. doi: 10.1136/jcp.2008.063149. Epub 2009 Aug 25.

    PubMed 19706632

  • Rubin MA, Kleter B, Zhou M, Ayala G, Cubilla AL, Quint WG, Pirog EC. Detection and typing of human papillomavirus DNA in penile carcinoma: evidence for multiple independent pathways of penile carcinogenesis. Am J Pathol. 2001 Oct;159(4):1211-8. doi: 10.1016/S0002-9440(10)62506-0.

    PubMed 11583947

  • Mannweiler S, Sygulla S, Beham-Schmid C, Razmara Y, Pummer K, Regauer S. Penile carcinogenesis in a low-incidence area: a clinicopathologic and molecular analysis of 115 invasive carcinomas with special emphasis on chronic inflammatory skin diseases. Am J Surg Pathol. 2011 Jul;35(7):998-1006. doi: 10.1097/PAS.0b013e3182147e59.

    PubMed 21681144

  • Castellsague X, Bosch FX, Munoz N, Meijer CJ, Shah KV, de Sanjose S, Eluf-Neto J, Ngelangel CA, Chichareon S, Smith JS, Herrero R, Moreno V, Franceschi S; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Male circumcision, penile human papillomavirus infection, and cervical cancer in female partners. N Engl J Med. 2002 Apr 11;346(15):1105-12. doi: 10.1056/NEJMoa011688.

    PubMed 11948269

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabozantinib in people with Penile Squamous Cell Carcinoma, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daniele Raggi, MD (+390223902402, daniele.raggi@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

response -rate by RECIST v1.1 criteria (time frame: 40 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03943602, which also lists 64 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.

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