A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer
A Randomized, Open Label, Phase 1/2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer
1 other identifier
interventional
37
1 country
8
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 cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2014
Longer than P75 for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2014
CompletedStudy Start
First participant enrolled
July 31, 2014
CompletedFirst Posted
Study publicly available on registry
August 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2021
CompletedResults Posted
Study results publicly available
March 2, 2023
CompletedMarch 2, 2023
January 1, 2023
7.4 years
July 31, 2014
December 14, 2022
February 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as a new or worsening AE that occurred in the window of first infusion of any study drug (Day 1) and within 28 days of the last infusion of study drug or the day before surgery, whichever occurred first. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
From first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196)
Number of Participants Who Had Surgical Complications Post-Resection
Number of participants who had surgical complications (for example; surgical site infection, intra-abdominal abscess, or perioperative leak during surgery) has been reported
30 days following discharge after surgery (up to Day 198)
Secondary Outcomes (6)
Number of Participants Who Became Eligible for Surgery
After completion of 24 weeks of treatment with study drug
Number of Participants in Whom R0 Resection Was Achieved
After completion of 24 weeks of treatment with study drug
Number of Participants in Whom R0 or R1 Resection Was Achieved
After completion of 24 weeks of treatment with study drug
Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
From randomization up to Week 52
Median Overall Survival
From randomization until death from any cause, assessed up to 4 years
- +1 more secondary outcomes
Study Arms (2)
FG-3019 + Gemcitabine + Nab-paclitaxel
EXPERIMENTALParticipants 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.
Gemcitabine + Nab-paclitaxel
ACTIVE COMPARATORParticipants 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.
Interventions
FG-3019 will be administered per dose and schedule specified in the arm group description.
Gemcitabine will be administered per dose and schedule specified in the arm group description.
Nab-paclitaxel will be administered per dose and schedule specified in the arm group description.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyntra Biolead
Study Sites (8)
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Georgetown University - Medstar Health Research Institute
Washington D.C., District of Columbia, 20007, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55404, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Virginia Mason Medical Center - Benaroya Research Institute
Seattle, Washington, 98101, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Information Desk
- Organization
- FibroGen, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Picozzi, MD
Virginia Mason Medical Center - Benaroya Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2014
First Posted
August 6, 2014
Study Start
July 31, 2014
Primary Completion
December 15, 2021
Study Completion
December 15, 2021
Last Updated
March 2, 2023
Results First Posted
March 2, 2023
Record last verified: 2023-01