A Phase 1/2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer

Overview

NCT ID: NCT02210559
Sponsor Protocol Number: FGCL-3019-069

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Study closed to enrollment

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

More information

Publications

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