MedTrace Logo

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

NCT02851381 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-10-07

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • John Glaspy, M.D. · Professor of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
83 Years
Max Age
83 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2016-09-30
Completion
2017-08-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02851381 on ClinicalTrials.gov