Clinical trial NCT02210559: A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer (Unresectable)
Keywords: locally
advanced
pancreatic
cancer
unresectable
pancreatic cancer
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* Male, or non-pregnant and, non-lactating female
* Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
* Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per National Comprehensive Cancer Network® \[NCCN®\] criteria)
* Laparoscopic confirmation that PDAC is locally advanced. Biliary stents are permitted.
* Measurable disease as defined by RECIST 1.1
* Eastern Cooperative Oncology Group (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 superior mesenteric artery (SMA) \>180°
* Previous (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer and in situ carcinomas)
* Major surgery, within 4 weeks prior to Day 1 on 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 participant in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation.
* Current abuse of alcohol or drugs

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196)
measure: Number of Participants Who Had Surgical Complications Post-Resection
timeFrame: 30 days following discharge after surgery (up to Day 198)
Secondary outcomes:
measure: Number of Participants Who Became Eligible for Surgery
timeFrame: After completion of 24 weeks of treatment with study drug
measure: Number of Participants in Whom R0 Resection Was Achieved
timeFrame: After completion of 24 weeks of treatment with study drug
measure: Number of Participants in Whom R0 or R1 Resection Was Achieved
timeFrame: After completion of 24 weeks of treatment with study drug
measure: Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
timeFrame: From randomization up to Week 52
measure: Median Overall Survival
timeFrame: From randomization until death from any cause, assessed up to 4 years
measure: Median Progression-Free Survival
timeFrame: From randomization until objective tumor progression or death, assessed up to 4 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Washington
country: United States
facility: Georgetown University - Medstar Health Research Institute
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute
state: Minnesota
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Seattle
country: United States
facility: Virginia Mason Medical Center - Benaroya Research Institute
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center - Benaroya Research Institute
name: Vincent Picozzi, MD
role: PRINCIPAL_INVESTIGATOR
References: