Status:
COMPLETED
A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer
Lead Sponsor:
FibroGen
Conditions:
Pancreatic Cancer (Unresectable)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase 1/2 trial to evaluate the safety, tolerability, and efficacy of FG-3019 administered with gemcitabine and nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic c...
Eligibility Criteria
Inclusion
- Key
- Male, or non-pregnant and, non-lactating female
- Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
- Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per National Comprehensive Cancer Network® \[NCCN®\] criteria)
- Laparoscopic confirmation that PDAC is locally advanced. Biliary stents are permitted.
- Measurable disease as defined by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate liver, bone marrow, and renal function
- Agree to use contraception per protocol
- Less than Grade 2 pre-existing peripheral neuropathy
- Key
Exclusion
- Prior chemotherapy or radiation for pancreatic cancer
- Solid tumor contact with superior mesenteric artery (SMA) \>180°
- Previous (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer and in situ carcinomas)
- Major surgery, within 4 weeks prior to Day 1 on study
- History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
- Exposure to another investigational drug within 42 days of first dosing visit, or 5 half-lives of the study product (whichever is longer)
- Uncontrolled intercurrent illness
- Any medical condition that, in the opinion of the Investigator, may pose a safety risk to a participant in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation.
- Current abuse of alcohol or drugs
Key Trial Info
Start Date :
July 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT02210559
Start Date
July 31 2014
End Date
December 15 2021
Last Update
March 2 2023
Active Locations (8)
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1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
3
Georgetown University - Medstar Health Research Institute
Washington D.C., District of Columbia, United States, 20007
4
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224