A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer
NCT ID: NCT02210559
Last Updated: 2023-03-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
37 participants
INTERVENTIONAL
2014-07-31
2021-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Pancreas Cancer
NCT03807999
Phase II Gemcitabine + Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma
NCT01146054
Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer
NCT01851174
A Phase 1 Study of Safety and Bioactivity With FG-3019 in Combination With Gemcitabine and Erlotinib for Subjects With Locally Advanced or Metastatic Pancreatic Cancer
NCT01181245
Phase 2 Study to Assess the Efficacy & Safety of Gemcitabine + Nab Paclitaxel With or Without Dociparstat in Metastatic Pancreatic Cancer Patients
NCT01461915
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FG-3019 + Gemcitabine + Nab-paclitaxel
Participants will receive FG-3019 35 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion on Days 1 and 15 of each treatment cycle and on Day 8 of the first cycle, gemcitabine 1000 mg/square meter (m\^2) and nab-paclitaxel 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles.
FG-3019
FG-3019 will be administered per dose and schedule specified in the arm group description.
Gemcitabine
Gemcitabine will be administered per dose and schedule specified in the arm group description.
Nab-paclitaxel
Nab-paclitaxel will be administered per dose and schedule specified in the arm group description.
Gemcitabine + Nab-paclitaxel
Participants will receive gemcitabine 1000 mg/ meter squared (m\^2) and nab-paclitaxel 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles.
Gemcitabine
Gemcitabine will be administered per dose and schedule specified in the arm group description.
Nab-paclitaxel
Nab-paclitaxel will be administered per dose and schedule specified in the arm group description.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FG-3019
FG-3019 will be administered per dose and schedule specified in the arm group description.
Gemcitabine
Gemcitabine will be administered per dose and schedule specified in the arm group description.
Nab-paclitaxel
Nab-paclitaxel will be administered per dose and schedule specified in the arm group description.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
FibroGen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vincent Picozzi, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Mason Medical Center - Benaroya Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
HonorHealth Research Institute
Scottsdale, Arizona, United States
University of California, Los Angeles
Los Angeles, California, United States
Georgetown University - Medstar Health Research Institute
Washington D.C., District of Columbia, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Virginia Mason Medical Center - Benaroya Research Institute
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Link to sponsor website where additional information is available regarding the investigational product and ongoing clinical trials.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FGCL-3019-069
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.