A Study of the Effectiveness and Safety of Experimental Pamrevlumab for Locally Advanced, Unresectable Pancreatic Cancer

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: unresectable pancreatic cancer, pancreatic cancer, chemotherapy, phase 3
Type: Drug study, Phase 3
Target:
10 Participants
Investigator:
Description
You have been asked to take part in a research study designed to test an experimental drug.

FibroGen, Inc. (FibroGen) is developing an experimental drug called pamrevlumab. Pamrevlumab is called “experimental” because it has not been approved by the FDA for doctors to prescribe to their patients. Pamrevlumab is a type of protein drug called a human monoclonal antibody. Monoclonal antibodies are similar to the antibodies that your body normally produces. Antibodies are made by your immune system and help you fight infections. Pamrevlumab interferes with connective tissue growth factor (CTGF). This is a protein that the body normally produces. When it produces too much CTGF, tumors may grow or spread.

This study will test whether pamrevlumab is safe and effective. It will be tested in patients with locally advanced unresectable (cannot be completely removed by surgery) pancreatic cancer. It will be combined with the currently approved chemotherapy treatment (gemcitabine and nab-paclitaxel).

Participants will be randomly assigned to 1 of 2 treatment groups:
• Treatment Group A: Gemcitabine + Nab-paclitaxel + Pamrevlumab
• Treatment Group B: Gemcitabine + Nab-paclitaxel + Placebo

A placebo is a substance that looks like the study drug, but has no active study drug. You have a 50% chance of being assigned to either group.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  1. Understand and sign informed consent; be willing to comply with study procedures, including surgery
  2. Age ≥ 18 years
  3. Be a male, or non-pregnant and non-lactating female
  4. Negative serum B-hCG pregnancy test at screening for women of childbearing potential
  5. Male subjects with partners of childbearing potential and female subjects of childbearing potential are required to use double barrier contraception methods during the conduct of the study and for 3 months after the last dose of study drug
  6. Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
  7. Locally advanced pancreatic cancer considered unresectable according to NCCN Guidelines® Version 2.2018 as determined by central imaging
  8. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors RECIST 1.1 criteria as determined by central imaging
  9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  10. Adequate liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x upper limit of normal (ULN), alkaline phosphatase <2.5 x ULN, and bilirubin ≤1.5 x ULN
  11. Adequate bone marrow function: platelets >100,000 cells/mm3, hemoglobin >9.0 g/dl and absolute neutrophil count (ANC) >1,500 cells/mm3
  12. Adequate renal function: creatinine < 1.5 x ULN, creatinine clearance ≥ 30 mL/min
  13. Less than grade 2 pre-existing peripheral neuropathy (per CTCAE)

Exclusion criteria:

  1. Prior chemotherapy or radiation for pancreatic cancer
  2. Previous (within the past 3 years) or concurrent malignancy diagnosis except non-melanoma skin cancer and in situ carcinomas (excluding in situ breast cancer)
  3. Major surgery within 4 weeks prior to signing informed consent form. Biliary stents are permitted.
  4. History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
  5. Any medical or surgical condition that may place the subject at increased risk while on study
  6. Any condition potentially decreasing compliance to study procedures
  7. Exposure to another investigational drug within 28 days of first dosing visit, or 5 half-lives of the investigational drug (whichever is longer)
  8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infections, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  9. Documented history of drug or alcohol abuse within 6 months of signing informed consent
  10. 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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study team will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
The treatment phase of the study lasts about 6 months (or six 28-day cycles).
Recruitment period
From July 22, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Contact
Marlene Alvarez
Research Topic
Conditions:
  • Pancreatic Cancer Non-resectable

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