UnknownPhase 2

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

Italy37 participantsStarted 2019-08-01

Plain-language summary

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

Age range18 Years – 75 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. Clinical stage N2-3 and/or M1 (TNM 2002).
✓. Locoregional relapse after prior major surgery/ies (either single or multiple).

✕. History of any one or more of the following cardiovascular conditions within the past 6 months:
✕. 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.

response -rate by RECIST v1.1 criteria

Timeframe: 40 months

NCT IDNCT03943602

SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-01

Daniele Raggi, MD

Who can participate

Age range18 Years – 75 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. Clinical stage N2-3 and/or M1 (TNM 2002).
✓. Locoregional relapse after prior major surgery/ies (either single or multiple).

✕. History of any one or more of the following cardiovascular conditions within the past 6 months:
✕. 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.