Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma

NCT02541903 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: F150330009 (UAB 14113)
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Penile Squamous Cell Carcinoma (PSCC)

Keywords

Epidermal growth factor receptor (EGFR),; Human Papillomavirus (HPV); Penile squamous cell carcinoma (PSCC); Gilotrif

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Progression Free Survival at 6 Months

  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.

  6 months following study treatment

Secondary Outcomes (3)

• Response Rate

  Baseline up to 3 months

• Overall Survival

  Baseline to death (assessed up to 30 months).

• Toxicities

  Baseline up to 18 months

Study Arms (1)

Gilotrif

EXPERIMENTAL

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).

Drug: Gilotrif

Interventions

Gilotrif DRUG

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

Gilotrif

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Afatinib

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

This study was closed early due to poor enrollment.

Results Point of Contact

• Title: Dr. Lisle Nabell, MD, Professor
• Organization: UAB

lnabell@uabmc.edu

(205) 934-3061

Study Officials

• Lisle Nabell, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Tanya Dorff, MD

  University of Southern California

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 4, 2015
• Study Start: October 1, 2015
• Primary Completion: January 26, 2019
• Study Completion: April 1, 2020
• Last Updated: April 14, 2020
• Results First Posted: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)