Trial · NCT02541903
Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma
NCT02541903, Phase 2, Terminated, University of Alabama at Birmingham; results first posted 2020-04-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma. Trials, record NCT02541903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02541903
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma
- NCT number
- NCT02541903
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Penile Squamous Cell Carcinoma (PSCC)
- Interventions
- Gilotrif
- First posted
- 2015-09-04
- Last updated
- 2020-04-14
- Results first posted
- 2020-04-14
- Limitations and caveats
- This study was closed early due to poor enrollment.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Progression Free Survival at 6 Months | 6 months following study treatment | Death will signify the time of progression free survival. Otherwise, the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 will be used to evaluate disease progression. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Response Rate | Baseline up to 3 months | The Response Evaluation Criteria in Solid Tumors guidelines version 1.1 and disease assessment scans (bone, CT) will be used to evaluate tumor response. |
| Secondary | Overall Survival | Baseline to death (assessed up to 30 months). | From date of study enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 30 months. |
| Secondary | Toxicities | Baseline up to 18 months | The number of adverse events and serious adverse events will be tabulated using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Progression Free Survival at 6 Months | 6 months following study treatment | 1 participant expired before receiving treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response Rate | Baseline up to 3 months | The response rate was calculated using those participants that showed regression or shrinkage at restaging scans. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Baseline to death (assessed up to 30 months). | days | MEAN | |
| SECONDARY | Toxicities | Baseline up to 18 months | Number of toxicities seen in patients | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Progression Free Survival at 6 Months | Gilotrif | 1 | Participants | ||
| Response Rate | Gilotrif | 2 | Participants | ||
| Overall Survival | Gilotrif | 83 | 90% Confidence Interval 82 to 95 | days | |
| Toxicities | Gilotrif | 5 | Number of toxicities seen in patients |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gilotrif | 8 | |
| Overall Study | COMPLETED | Gilotrif | 7 | |
| Overall Study | NOT COMPLETED | Gilotrif | 1 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Decreased platelet count | Vascular disorders | Gilotrif | 1 | 8 | 1 |
| other | cellulitis | Infections and infestations | Gilotrif | 1 | 8 | 1 |
| other | Pain in scrotal region | General disorders | Gilotrif | 1 | 8 | 1 |
| other | Anemia | Vascular disorders | Gilotrif | 1 | 8 | 1 |
| serious | Fatigue | General disorders | Gilotrif | 1 | 8 | 1 |
| serious | Death | General disorders | Gilotrif | 1 | 8 | 1 |
| serious | Deep Venous Thrombosis | Vascular disorders | Gilotrif | 1 | 8 | 1 |
| serious | Hospitalization | Infections and infestations | Gilotrif | 1 | 8 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gilotrif | 4 | 8 |
| Total, other adverse events | Gilotrif | 4 | 8 |
| Total, serious adverse events | Gilotrif | 4 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02541903
GET https://conductscience.org/api/trials/v1/NCT02541903/registered