NCT02851381

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 83 Years – 83 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-09-01
• Completion: 2017-08-01
• First posted: 2016-08-01
• Last updated: 2016-10-07