Locally Advanced, Unresectable Pancreatic Cancer MedDRA version: 21.0 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Pamrevlumab
Product Code: FG-3019
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: PAMREVLUMAB
CAS Number: 946415-13-0
Current Sponsor code: FG-3019
Other descriptive name
Sponsors
FibroGen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 highly effective contraception methods during the conduct of the study and for 6 months after the last dose of therapy 6. Histologically or cytologically 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 11. Adequate bone marrow function 12. Adequate renal function 13. Less than grade 2 pre-existing peripheral neuropathy (per CTCAE) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
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. History of allergy or hypersensitivity to any of the chemotherapy agents being prescribed or their excipients 6. Any medical or surgical condition that may place the subject at increased risk while on study 7. Any condition potentially decreasing compliance to study procedures 8. Exposure to another investigational drug within 28 days of first dosing visit, or 5 half lives of the investigational drug (whichever is longer) 9. 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 10. Documented history of drug or alcohol abuse within 6 months of signing informed consent 11. 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 12. Subjects with a history of; interstitial pneumonia, HCV, HBV or HIV infection 13. Subjects who have been administered a live vaccine within four weeks prior to the first administration of therapy 14. Subjects who cannot stop chronic medications that inhibit or induce CYP2C8 or CYP3A4 15. Subjects with poorly controlled comorbid conditions, including congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), uncontrolled diabetes mellitus (DM) or neurologic disorders (not acuttely related to pancreatic cancer) or limited function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab in combination with either gemcitabine plus nab-paclitaxel or FOLFIRINOX when compared to treatment with gemcitabine plus nab-paclitaxel alone in locally advanced, unresectable pancreatic cancer.;Secondary Objective: To evaluate the effect of neoadjuvant treatment with pamrevlumab in combination with gemcitabine plus nab-paclitaxel or gemcitabine plus nab-paclitaxel alone on resection rates.;Primary end point(s): - Overall survival (OS) - Key Secondary Endpoint- Event-Free Survival (EFS) for Accelerated Approval:;Timepoint(s) of evaluation of this end point: - Time from randomization to death due to any cause. - The EFS endpoint would be a composite time-to-event endpoint, the event being 'treatment failure' defined as the earliest occurrence of: - Failure to achieve disease-free status locally after completion of neoadjuvant treatment and/or after surgery (i.e., resection failure or progression that precludes surgery) - Local or distant recurrence, or - Death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression-free survival (PFS) - RECIST 1.1 – Best Overall Objective Response Rate (ORR), defined as the proportion of patients who achieve CR (Complete Response) or PR (Partial Response) during treatment period ;Timepoint(s) of evaluation of this end point: Analysis of Progression-free Survival (PFS) PFS is defined as the time from randomization until disease progression or death, whichever occurs first. Analysis of Best Overall Objective Response Rate (ORR) Best overall objective response rate (ORR) is one of the secondary endpoints where objective response is defined as a complete response (CR) or partial response (PR) according to RECIST 1.1. Detailed information is summarized within the protocol. | — |
Countries
Australia, Austria, Belgium, Canada, China, France, Germany, Israel, Italy, Korea, Republic of, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
FibroGen, Inc.
Outcome results
None listed