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Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02541903
Recruitment Status : Terminated (poor overall accrual)
First Posted : September 4, 2015
Results First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Lisle Nabell, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Penile Squamous Cell Carcinoma (PSCC)
Intervention Drug: Gilotrif
Enrollment 8
Recruitment Details The study was open to accrual between 10/6/2015 and 2/26/2019. Two sites were involved - the University of Alabama at Birmingham, and the University of Southern California.
Pre-assignment Details  
Arm/Group Title Gilotrif
Hide Arm/Group Description

Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks).

Gilotrif: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur.

Period Title: Overall Study
Started 8
Completed 7
Not Completed 1
Reason Not Completed
Death             1
Arm/Group Title Gilotrif
Hide Arm/Group Description

Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks).

Gilotrif: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur.

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
1 patient expired after signing consent but before starting treatment
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
52.4
(33 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female 0
Male 8
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native 0
Asian 0
Native Hawaiian or Other Pacific Islander 0
Black or African American 1
White 6
More than one race 0
Unknown or Not Reported 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Number of Participants With Progression Free Survival at 6 Months
Hide Description 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.
Time Frame 6 months following study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant expired before receiving treatment
Arm/Group Title Gilotrif
Hide Arm/Group Description:

Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks).

Gilotrif: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur.

Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
1
  14.3%
2.Secondary Outcome
Title Response Rate
Hide Description The Response Evaluation Criteria in Solid Tumors guidelines version 1.1 and disease assessment scans (bone, CT) will be used to evaluate tumor response.
Time Frame Baseline up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
The response rate was calculated using those participants that showed regression or shrinkage at restaging scans.
Arm/Group Title Gilotrif
Hide Arm/Group Description:

Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks).

Gilotrif: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur.

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
2
3.Secondary Outcome
Title Overall Survival
Hide Description 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.
Time Frame Baseline to death (assessed up to 30 months).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gilotrif
Hide Arm/Group Description:

Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks).

Gilotrif: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur.

Overall Number of Participants Analyzed 8
Mean (90% Confidence Interval)
Unit of Measure: days
83
(82 to 95)
4.Secondary Outcome
Title Toxicities
Hide Description 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.
Time Frame Baseline up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gilotrif
Hide Arm/Group Description:

Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks).

Gilotrif: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur.

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Number of toxicities seen in patients
5
Time Frame Adverse were collected every month during the study period and post-treatment (within 30 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gilotrif
Hide Arm/Group Description

Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks).

Gilotrif: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur.

All-Cause Mortality
Gilotrif
Affected / at Risk (%)
Total   4/8 (50.00%)    
Hide Serious Adverse Events
Gilotrif
Affected / at Risk (%) # Events
Total   4/8 (50.00%)    
General disorders   
Fatigue  1 [1]  1/8 (12.50%)  1
Death  1 [2]  1/8 (12.50%)  1
Infections and infestations   
Hospitalization  1 [3]  1/8 (12.50%)  1
Vascular disorders   
Deep Venous Thrombosis  1 [4]  1/8 (12.50%)  1
1
Term from vocabulary, CTCAE 4.03
Indicates events were collected by systematic assessment
[1]
Grade 2 fatigue requiring hospitalization
[2]
Patient died on C1D1 before starting treatment
[3]
Was admitted to the hospital for new drainage from L inguinal mass on 8/12/2017 , treated with Vanco/Zosyn and hyration. was given diaudid and norco for pain PRN. was discharged home on 8/15/2017
[4]
Grade 3
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gilotrif
Affected / at Risk (%) # Events
Total   4/8 (50.00%)    
General disorders   
Pain in scrotal region  1  1/8 (12.50%)  1
Infections and infestations   
cellulitis  1  1/8 (12.50%)  1
Vascular disorders   
Decreased platelet count  1  1/8 (12.50%)  1
Anemia  1  1/8 (12.50%)  1
1
Term from vocabulary, CTCAE 4.03
Indicates events were collected by systematic assessment
This study was closed early due to poor enrollment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lisle Nabell, MD, Professor
Organization: UAB
Phone: (205) 934-3061
EMail: lnabell@uabmc.edu
Layout table for additonal information
Responsible Party: Lisle Nabell, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02541903    
Other Study ID Numbers: F150330009 (UAB 14113)
First Submitted: August 24, 2015
First Posted: September 4, 2015
Results First Submitted: March 3, 2020
Results First Posted: April 14, 2020
Last Update Posted: April 14, 2020