Trial · NCT03943602
Cabozantinib in Patients With Advanced Penile Squamous Cell Carcinoma (PSCC) (CaboPen)
NCT03943602, Phase 2, Unknown, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cabozantinib in Patients With Advanced Penile Squamous Cell Carcinoma (PSCC) (CaboPen). Trials, record NCT03943602. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03943602
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cabozantinib in Patients With Advanced Penile Squamous Cell Carcinoma (PSCC) (CaboPen)
- NCT number
- NCT03943602
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 37 participants, estimated
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Conditions
- Penile Squamous Cell Carcinoma
- Interventions
- Cabozantinib
- First posted
- 2019-05-09
- Last updated
- 2021-02-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | response -rate by RECIST v1.1 criteria | 40 months | Assessment of response-rate by RECIST v1.1. Complete response + partial response |
| Secondary | Incidence of treatment-Emergent Adverse Event(safety and tolerability) | 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. |
| Secondary | Pathologic complete response (pCR) | 40 months | Histological report of radical surgery |
| Secondary | Progression-free survival (PFS). | 40 months | Recist 1.1 criteria |
| Secondary | Overall Survival (OS). | 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. |
| Secondary | Variations of the Quality of Life | 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 |
| Secondary | FDG-PET/CT response rate according to EORTC criteria | 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). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers64
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03943602
GET https://conductscience.org/api/trials/v1/NCT03943602/papers?page=2