Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

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

Details

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.

Keywords

Pancreatic Cancer (Unresectable) locally advanced pancreatic cancer unresectable pancreatic cancer Pancreatic Neoplasms Gemcitabine Paclitaxel Nab-paclitaxel

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Los Angeles
    Los Angeles California 90095 United States
  • HonorHealth Research Institute
    Scottsdale Arizona 85258 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
FibroGen
Links
Link to sponsor website where additional information is available regarding the investigational product and ongoing clinical trials.
ID
NCT02210559
Phase
Phase 1/2
Study Type
Interventional
Last Updated