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

NCT ID: NCT02851381

Last Updated: 2016-10-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-08-31

Brief 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.

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FG-3019

Treatment of Pancreatic Cancer with FG-3019

Group Type: OTHER

FG-3019

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 83 Years
• Maximum Eligible Age: 83 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Glaspy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine

Other Identifiers

16-001170

Identifier Type: -

Identifier Source: org_study_id