Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Penile Squamous Cell Carcinoma (PSCC)||Drug: Gilotrif||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma Following Systemic Therapy|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||January 26, 2019|
|Actual Study Completion Date :||April 2020|
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).
Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur.
- Number of Participants With Progression Free Survival at 6 Months [ Time Frame: 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.
- Response Rate [ Time Frame: 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.
- Overall Survival [ Time Frame: 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.
- Toxicities [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541903
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Lisle Nabell, MD||University of Alabama at Birmingham|
|Study Chair:||Tanya Dorff, MD||University of Southern California|