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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02851381
• Other study ID #: 16-001170
• Status: Withdrawn
• Phase: N/A
• First received: July 26, 2016
• Last updated: October 6, 2016
• Start date: August 2016
• Est. completion date: August 2017

Study information

• Verified date: July 2016
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 83 Years to 83 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FG-3019 treatment regimen to increase OS (overall survival)		7.7 months	No