Overview

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

Status:
Withdrawn
Trial end date:
2017-08-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Treatments:
Antibodies, Monoclonal
Criteria
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