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

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study ID
NCT03943602
Phase
PHASE2
Status
Unknown

Conditions

  • Penile Squamous Cell Carcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Aug 1, 2019
Status verified
Feb 2021
Primary completion
Jun 1, 2022
Completion
Sep 1, 2022

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

response -rate by RECIST v1.1 criteria [ Time Frame: 40 months ]

Central Contacts

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