A Phase 2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer
Conditions
Unresectable Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
locally, advanced, pancreatic, cancer, unresectable
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: FG-3019 Type: Drug
Name: Gemcitabine Type: Drug
Name: Nab-paclitaxel Type: Drug
Overall Status
Recruiting
Summary
This is a Phase 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.
Detailed Description
Each subject may receive up to six cycles of treatment (each treatment cycle is 28 days). Qualified subjects will be required to undergo two core tumor biopsies performed by EUS (endoscopic ultrasound) at baseline and end of treatment. Tumor response will be evaluated by changes in CT scan, FDG-PET and CA 19-9.

Subject 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 up to 5 years until disease progression or survival.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Key Inclusion Criteria:

- Male or non-pregnant, non-lactating female

- Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)

- Pre-treatment tumor biopsy material adequate for evaluation of study endpoint

- Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per NCCN criteria)

- Laparoscopic confirmation that PDAC is locally advanced

- Measurable disease as defined by RECIST (tumor staging must have occurred within 2 weeks prior to Cycle 1 Day 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

- 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

- Participation in another clinical protocol or investigational trial within 60 days prior to Day 1

- 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
Location
Virginia Mason Medical Center - Benroya Research Institute
Seattle, Washington, United States
Status: Recruiting
Contact: Mark Kowalczyk, BS - 206-342-6907 - mark.kowalczyk@vmmc.org
Start Date
July 2014
Completion Date
June 2021
Sponsors
FibroGen
Source
FibroGen
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page