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

Study Overview

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

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.

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.

Pancreatic Cancer

DRUG: FG-3019

16-001170

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-07-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-10-06
First Submitted that Met QC Criteria 2016-07-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-10-07
First Posted (ESTIMATED) 2016-08-01	Results First Posted N/A	Last Verified 2016-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: FG-3019 Treatment of Pancreatic Cancer with FG-3019	DRUG: FG-3019 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

Participant Group/Arm

Intervention/Treatment

OTHER: FG-3019

Treatment of Pancreatic Cancer with FG-3019

DRUG: FG-3019

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

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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
FEMALE

Sexes Eligible for Study:
83 Years

Accepts Healthy Volunteers:

Signed Consent form
Have adequate liver function
Have adequate bone marrow function

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: John Glaspy, M.D., Professor of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record