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

NCT02851381 | Withdrawn

• 1 other identifier: 16-001170
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• FG-3019 treatment regimen to increase OS (overall survival)

  7.7 months

Study Arms (1)

FG-3019

OTHER

Treatment of Pancreatic Cancer with FG-3019

Drug: FG-3019

Interventions

FG-3019 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

FG-3019

Eligibility Criteria

• Age: 83 Years - 83 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Signed Consent form
• Have adequate liver function
• Have adequate bone marrow function

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

pamrevlumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• John Glaspy, M.D.

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 1, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: August 1, 2017
• Last Updated: October 7, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share