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A Phase 1/2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in 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 : Active, not recruiting
First Posted : August 6, 2014
Last Update Posted : February 15, 2019
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

Detailed Description:

Each subject may receive up to six cycles of treatment (each treatment cycle is 28 days). Tumor tissue will be collected during resection for biomarker analysis. EUS core tumor biopsies will be collected pre/post treatment at participating centers. Tumor response will be evaluated by changes in CT scan, FDG-PET, CA 19-9, and NCCN® guidelines.

Subjects who complete 6 cycles of treatment will be evaluated for surgical exploration for possible R0 resection. Subjects who undergo surgery will be evaluated for surgical complications for an additional 30 days following discharge from surgery. All subjects will be followed for safety for 28 days following their last dose with study drug. Blood samples will be collected periodically for the assessment of pharmacokinetics (PK) and pharmacodynamics (PD).

All subjects, including those who discontinue from the study during the treatment period without evidence of disease progression, will be followed for at least 28 weeks post End of Treatment for disease progression, survival, and follow-on treatment for pancreatic cancer.

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 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
FG-3019 + Gemcitabine + Nab-paclitaxel
 Drug: FG-3019
FG-3019 is administered in TREATMENT ARM A ONLY on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. The dose level is 35 mg/kg.

Drug: Gemcitabine
Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. The dose level is 1000 mg/m2.
Other Name: Gemzar

Drug: Nab-paclitaxel
Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. The dose level is 125 mg/m2.
Other Name: Abraxane
Arm B
Gemcitabine + Nab-paclitaxel
 Drug: Gemcitabine
Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. The dose level is 1000 mg/m2.
Other Name: Gemzar

Drug: Nab-paclitaxel
Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. The dose level is 125 mg/m2.
Other Name: Abraxane


Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: Through 28 days following the last dose of study treatment ]
    Asses the treatment-emergent adverse events (TEAEs), serious treatment-emergent adverse events (TESAEs), clinical laboratory tests, and discontinuation of treatment for treatment-related TEAEs.

  2. Surgical safety with respect to complication rates post resection [ Time Frame: 30 days following discharge after surgery ]
  3. The proportion of subjects who become eligible for surgery [ Time Frame: After completion of 24 weeks of treatment with study drug ]
  4. The proportion of subjects in whom R0 resection is achieved [ Time Frame: After completion of 24 weeks of treatment with study drug ]
  5. The proportion of subjects in R0 or R1 resection is achieved [ Time Frame: After completion of 24 weeks of treatment with study drug ]
  6. Tumor response rates [ Time Frame: After completion of 24 weeks of treatment with study drug ]
    Measured by: complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), at least 50% reduction from baseline in serum CA19-9, or at least 30% reduction from baseline in SUV[max] assessed by FDG-PET

  7. Median overall survival and 1-year survival rate [ Time Frame: At least 28 weeks following completion of 24 weeks of treatment (52 weeks) ]
  8. Median progression free survival and 1-year progression free rate [ Time Frame: At least 28 weeks following completion of 24 weeks of treatment (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, non-lactating female
  • Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
  • Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per NCCN criteria)
  • Laparoscopic confirmation that PDAC is locally advanced. Biliary stents are permitted
  • Measurable disease as defined by RECIST 1.1
  • 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 SMA > 180°
  • Previous (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer or in situ carcinoma of the cervix)
  • Major surgery within 4 weeks prior to Day 1 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 subject 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: February 15, 2019
Last Verified: February 2019
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