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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02210559
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : May 3, 2022
Sponsor:
Information provided by (Responsible Party):
FibroGen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer (Unresectable) Drug: FG-3019 Drug: Gemcitabine Drug: Nab-paclitaxel Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 31, 2014
Actual Primary Completion Date : December 15, 2021
Actual Study Completion Date : December 15, 2021

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Arms and Interventions
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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 Name: Gemzar

Drug: Nab-paclitaxel
Nab-paclitaxel will be administered per dose and schedule specified in the arm group description.
Other Name: 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 Name: Gemzar

Drug: Nab-paclitaxel
Nab-paclitaxel will be administered per dose and schedule specified in the arm group description.
Other Name: Abraxane


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Through 28 days following the last dose of study treatment (up to Day 196) ]
  2. Surgical Safety: Number of Participants Having Post- Resection Complications [ Time Frame: 30 days following discharge after surgery (up to Day 198) ]

Secondary Outcome Measures :
  1. Percentage of Participants who Become Eligible for Surgery [ Time Frame: After completion of 24 weeks of treatment with study drug ]
  2. Percentage of Participants in Whom R0 Resection is Achieved [ Time Frame: After completion of 24 weeks of treatment with study drug ]
  3. Percentage of Participants in Whom R0 or or R1 Resection is Achieved [ Time Frame: After completion of 24 weeks of treatment with study drug ]
  4. Number of Participants With Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: After completion of 24 weeks of treatment with study drug ]
  5. Median Overall Survival [ Time Frame: 52 weeks ]
  6. Median Progression-Free Survival [ Time Frame: 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210559


Locations
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United States, Arizona
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, District of Columbia
Georgetown University - Medstar Health Research Institute
Washington, District of Columbia, United States, 20007
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55404
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Washington
Virginia Mason Medical Center - Benaroya Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
FibroGen
Investigators
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Principal Investigator: Vincent Picozzi, MD Virginia Mason Medical Center - Benaroya Research Institute
More Information
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Additional Information:

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Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT02210559    
Other Study ID Numbers: FGCL-3019-069
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: April 2022
Keywords provided by FibroGen:
locally
advanced
pancreatic
 cancer
unresectable
pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs