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

Sponsor

Jonsson Comprehensive Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02851381

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: FG-3019	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

FG-3019 treatment regimen to increase OS (overall survival) [7.7 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

83 Years to 83 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Jonsson Comprehensive Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonsson Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT02851381

Other Study ID Numbers:

16-001170

First Posted:

Aug 1, 2016

Last Update Posted:

Oct 7, 2016

Last Verified:

Jul 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Oct 7, 2016