Back to resultsA Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer
Primary Purpose
Pancreatic Cancer (Unresectable)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FG-3019
Gemcitabine
Nab-paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer (Unresectable) focused on measuring locally, advanced, pancreatic, cancer, unresectable, pancreatic cancer
Eligibility 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
Sites / Locations
- HonorHealth Research Institute
- University of California, Los Angeles
- Georgetown University - Medstar Health Research Institute
- Mayo Clinic Florida
- Ochsner Clinic Foundation
- Virginia Piper Cancer Institute
- Thomas Jefferson University
- Virginia Mason Medical Center - Benaroya Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FG-3019 + Gemcitabine + Nab-paclitaxel
Gemcitabine + Nab-paclitaxel
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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'.
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
Secondary Outcome Measures
Number of Participants Who Became Eligible for Surgery
Number of Participants in Whom R0 Resection Was Achieved
R0 resection was determined by pathological examination of the surgical specimen after resection.
Number of Participants in Whom R0 or R1 Resection Was Achieved
R0 or R1 resection was determined by pathological examination of the surgical specimen after resection.
Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
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.
Median Overall Survival
Overall survival was defined as the time from randomization until death from any cause.
Median Progression-Free Survival
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02210559
Brief Title
A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 31, 2014 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FibroGen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer (Unresectable)
Keywords
locally, advanced, pancreatic, cancer, unresectable, pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FG-3019 + Gemcitabine + Nab-paclitaxel
Arm Type
Experimental
Arm Description
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.
Arm Title
Gemcitabine + Nab-paclitaxel
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
FG-3019
Intervention Description
FG-3019 will be administered per dose and schedule specified in the arm group description.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine will be administered per dose and schedule specified in the arm group description.
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Other Intervention Name(s)
Abraxane
Intervention Description
Nab-paclitaxel will be administered per dose and schedule specified in the arm group description.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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'.
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)
Title
Number of Participants Who Had Surgical Complications Post-Resection
Description
Number of participants who had surgical complications (for example; surgical site infection, intra-abdominal abscess, or perioperative leak during surgery) has been reported
Time Frame
30 days following discharge after surgery (up to Day 198)
Secondary Outcome Measure Information:
Title
Number of Participants Who Became Eligible for Surgery
Time Frame
After completion of 24 weeks of treatment with study drug
Title
Number of Participants in Whom R0 Resection Was Achieved
Description
R0 resection was determined by pathological examination of the surgical specimen after resection.
Time Frame
After completion of 24 weeks of treatment with study drug
Title
Number of Participants in Whom R0 or R1 Resection Was Achieved
Description
R0 or R1 resection was determined by pathological examination of the surgical specimen after resection.
Time Frame
After completion of 24 weeks of treatment with study drug
Title
Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Description
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.
Time Frame
From randomization up to Week 52
Title
Median Overall Survival
Description
Overall survival was defined as the time from randomization until death from any cause.
Time Frame
From randomization until death from any cause, assessed up to 4 years
Title
Median Progression-Free Survival
Description
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.
Time Frame
From randomization until objective tumor progression or death, assessed up to 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Picozzi, MD
Organizational Affiliation
Virginia Mason Medical Center - Benaroya Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HonorHealth Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Georgetown University - Medstar Health Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Virginia Mason Medical Center - Benaroya Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.fibrogen.com/
Description
Link to sponsor website where additional information is available regarding the investigational product and ongoing clinical trials.
Learn more about this trial
A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer
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