Compassionate Single Subject Use of FG-3019 (FibroGen) in Locally Advanced, Unresectable Pancreatic Cancer

Study Overview
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Brief Summary
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Single compassionate use subject is an 83 year old woman with a history of lymph node positive breast cancer and recently diagnosed pancreatic cancer in May. With an Eastern Cooperative Oncology Group (ECOG) of 2, it is felt that she cannot tolerate more aggressive chemotherapy. The investigators propose to administer FG-3019 on a compassionate pleas basis in combination with gemzar. The patient is currently being treated and is tolerating gemzar.

Detailed Description
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The FG-3019 treatment will be administered over a 28-day cycle: Dose: 35 mg/kg Route: IV over one hour following completion of gemcitabine infusion Schedule: Days 1, 8, and 15 Please note that Day 8 infusion will on be completed during the first treatment cycle On Drug Evaluation The patient will be seen prior to every FG-3019 treatment by the treating physician. The following procedures will be conducted at each visit: History and thorough symptom assessment Physical examination Laboratory assessments (these can be collected up to 3 days prior to treatment): Complete blood count (CBC) and differential Comprehensive Metabolic Panel (Chemistry): bicarbonate, blood, urea, nitrogen (BUN), calcium, creatinine, glucose, potassium, sodium Liver Function Tests: Alkaline phosphatase (ALP), Alanine transaminase (ALT), Aspartate transaminase (AST), total bilirubin Carbohydrate antigen (CA) 19-9 ECGs will be conducted during the screening and end of treatment visits. CT scans of the chest and abdomen will be done every 12 to 16 weeks. All of these data will be recorded and stored with their source documents.

Official Title
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Compassionate Single Subject Use of FG-3019 in Locally Advanced, Unresectable Pancreatic Cancer (Emergency Use of a Test Article)

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: FG-3019


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Consent form Have adequate liver function Have adequate bone marrow function Exclusion Criteria: History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies Any medical or surgical condition that may place the subject at increased risk while on treatment Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with treatment requirements Current abuse of alcohol or drugs

Ages Eligible for Study
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Minimum Age: 83 Years
Maximum Age: 83 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FG-3019<br>Treatment of Pancreatic Cancer with FG-3019 | Drug: FG-3019<br>* The FG-3019 treatment will be administered over a 28-day cycle: Dose: 35 mg/kg Route: IV over one hour following completion of gemcitabine infusion Schedule: Days 1, 8, and 15 Please note that Day 8 infusion will on be completed during the first treatment cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FG-3019 treatment regimen to increase OS (overall survival) |  | 7.7 months |