A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT02210559 |
Recruitment Status :
Completed
First Posted : August 6, 2014
Last Update Posted : May 3, 2022
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Condition or disease | Intervention/treatment | Phase |
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Pancreatic Cancer (Unresectable) | Drug: FG-3019 Drug: Gemcitabine Drug: Nab-paclitaxel | Phase 1 Phase 2 |
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 |

Arm | Intervention/treatment |
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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.
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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.
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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 |
- 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) ]
- Surgical Safety: Number of Participants Having Post- Resection Complications [ Time Frame: 30 days following discharge after surgery (up to Day 198) ]
- Percentage of Participants who Become Eligible for Surgery [ Time Frame: After completion of 24 weeks of treatment with study drug ]
- Percentage of Participants in Whom R0 Resection is Achieved [ Time Frame: After completion of 24 weeks of treatment with study drug ]
- Percentage of Participants in Whom R0 or or R1 Resection is Achieved [ Time Frame: 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: After completion of 24 weeks of treatment with study drug ]
- Median Overall Survival [ Time Frame: 52 weeks ]
- Median Progression-Free Survival [ Time Frame: 52 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Vincent Picozzi, MD | Virginia Mason Medical Center - Benaroya Research Institute |
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 |
locally advanced pancreatic |
cancer unresectable pancreatic cancer |
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 |