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

October 6, 2016 updated by: Jonsson Comprehensive Cancer Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

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

83 years to 83 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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
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 first treatment cycle

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

  • Principal Investigator: John Glaspy, M.D., Professor of Medicine

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

August 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimate)

August 1, 2016

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-001170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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