- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02541903
Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma
April 10, 2020 updated by: Lisle Nabell, University of Alabama at Birmingham
A Phase 2 Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma Following Systemic Therapy
Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease.
Supportive evidence for the value of systemic therapy does not exist for this disease and there are no agents currently approved by regulatory agencies.
This study will evaluate the drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy.
Gilotrif has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins that are also found in PSCC.
The drug has the potential for some patients to exhibit a response contributing to a greater quality of life.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This is a non-randomized trial phase 2 trial in which the drug Gilotrif will be administered at an oral dosage of 40 mg daily.
This will continue until there is disease progression or severe toxicities.
Patients will undergo a clinical exam every 4 weeks as well as have blood collected.
Radiographic scans will be done every 8 weeks.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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California
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Los Angeles, California, United States, 90033
- University of Southern California
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Histologically or cytologically confirmed PSCC.
- Patients with metastatic or locally advanced unresectable PSCC.
- Progressive disease after ≥1 prior chemotherapy regimens.
- Measurable disease by RECIST 1.1 criteria.
- Prior regimen within 6 months
- ECOG performance status 0-2.
Adequate organ function, defined as all of the following:
- Absolute neutrophil count (ANC) >1500 /mm3. Platelet count >100,000/ mm3.
- Estimated creatinine clearance ≥ 45ml/min.
- Total Bilirubin <1.5 times upper limit of institutional normal; Aspartate amino transferase (AST) or alanine amino transferase (ALT) <2.5 times the upper limit of institutional normal (ULN).
- Hemoglobin ≥8.5 g/dl.
- Resolution of all acute toxic effects of prior chemotherapy or surgical procedures to NCI CTCAE version 4.03 grade <1, in the opinion of the Treating Physician.
- Ability to understand and willingness to sign a written informed consent. Age ≥18 years or age of majority at the participating site, whichever is greater.
- Availability of 20 archival formalin-fixed paraffin embedded tumor tissue slides.
Exclusion Criteria:
- Patients will have recovered from toxicities from prior systemic anticancer treatment or local therapies.
- Prior EGFR inhibitors.
- Major surgery within 4 weeks or minor surgery within 2 weeks before registration or scheduled for surgery during the projected course of the study. Wounds will be completely healed prior to study entry and patients recovered from all toxicities from surgery. Placement of vascular access device is not considered major or minor surgery in this regard.
- Prior radiation therapy is allowed as long as the irradiated area was not the sole source of measurable disease and radiotherapy was completed with recovery from toxicity, at least 3 weeks prior to enrollment. If the irradiated area is the only site of disease, there will be progressive disease.
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to registration.
- Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug.
- Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
- Requiring treatment with any of the prohibited concomitant medications listed in the protocol that cannot be stopped for the duration of trial participation.
- Known pre-existing interstitial lung disease.
- Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption).
- Active hepatitis B infection (defined as presence of Hep BsAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.
- Meningeal carcinomatosis.
- Patients with active brain or subdural metastases are not eligible, unless they have completed local (radiation) therapy and have discontinued the use of corticosteroids or have been on stable dose of corticosteroids for at least 4 weeks before starting study treatment. Any symptoms attributed to brain metastases will be stable for at least 4 weeks before starting study treatment.
- Any active or uncontrolled infection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Gilotrif
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).
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Patients will take a single oral dose of Gilotrif each day starting at 40 mg.
Dose escalation and reductions can occur.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Progression Free Survival at 6 Months
Time Frame: 6 months following study treatment
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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.
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6 months following study treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: Baseline up to 3 months
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The Response Evaluation Criteria in Solid Tumors guidelines version 1.1 and disease assessment scans (bone, CT) will be used to evaluate tumor response.
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Baseline up to 3 months
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Overall Survival
Time Frame: Baseline to death (assessed up to 30 months).
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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.
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Baseline to death (assessed up to 30 months).
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Toxicities
Time Frame: Baseline up to 18 months
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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.
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Baseline up to 18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lisle Nabell, MD, University of Alabama at Birmingham
- Study Chair: Tanya Dorff, MD, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
January 26, 2019
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
August 24, 2015
First Submitted That Met QC Criteria
September 3, 2015
First Posted (Estimate)
September 4, 2015
Study Record Updates
Last Update Posted (Actual)
April 14, 2020
Last Update Submitted That Met QC Criteria
April 10, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F150330009 (UAB 14113)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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