A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer

February 2, 2023 updated by: FibroGen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University - Medstar Health Research Institute
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Virginia Piper Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center - Benaroya Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: FG-3019
FG-3019 will be administered per dose and schedule specified in the arm group description.
Drug: Gemcitabine
Gemcitabine will be administered per dose and schedule specified in the arm group description.
Other Names:
  • Gemzar
Drug: Nab-paclitaxel
Nab-paclitaxel will be administered per dose and schedule specified in the arm group description.
Other Names:
  • Abraxane
Active Comparator: 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.
Drug: Gemcitabine
Gemcitabine will be administered per dose and schedule specified in the arm group description.
Other Names:
  • Gemzar
Drug: Nab-paclitaxel
Nab-paclitaxel will be administered per dose and schedule specified in the arm group description.
Other Names:
  • Abraxane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: 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)
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
Time Frame: 30 days following discharge after surgery (up to Day 198)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Became Eligible for Surgery
Time Frame: After completion of 24 weeks of treatment with study drug
After completion of 24 weeks of treatment with study drug
Number of Participants in Whom R0 Resection Was Achieved
Time Frame: After completion of 24 weeks of treatment with study drug
R0 resection was determined by pathological examination of the surgical specimen after resection.
After completion of 24 weeks of treatment with study drug
Number of Participants in Whom R0 or R1 Resection Was Achieved
Time Frame: After completion of 24 weeks of treatment with study drug
R0 or R1 resection was determined by pathological examination of the surgical specimen after resection.
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)
Time Frame: From randomization up to Week 52
CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduced in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From randomization up to Week 52
Median Overall Survival
Time Frame: From randomization until death from any cause, assessed up to 4 years
Overall survival was defined as the time from randomization until death from any cause.
From randomization until death from any cause, assessed up to 4 years
Median Progression-Free Survival
Time Frame: From randomization until objective tumor progression or death, assessed up to 4 years
Progression-free survival was defined as the time from randomization until objective tumor progression or death. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
From randomization until objective tumor progression or death, assessed up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FibroGen

Investigators

  • Principal Investigator: Vincent Picozzi, MD, Virginia Mason Medical Center - Benaroya Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2014

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FGCL-3019-069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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