A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer

FibroGen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pancreatic Cancer (Unresectable)

Treatments: Drug: Gemcitabine; Drug: FG-3019; Drug: Nab-paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02210559

FGCL-3019-069

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

FG-3019 + Gemcitabine + Nab-paclitaxel

Experimental group

Description:

Participants will receive FG-3019 35 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion on Days 1 and 15 of each treatment cycle and on Day 8 of the first cycle, gemcitabine 1000 mg/square meter (m\^2) and nab-paclitaxel 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles.

Treatment:

Drug: Nab-paclitaxel

Drug: FG-3019

Drug: Gemcitabine

Gemcitabine + Nab-paclitaxel

Active Comparator group

Description:

Participants will receive gemcitabine 1000 mg/ meter squared (m\^2) and nab-paclitaxel 125 mg/m\^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles.

Treatment:

Drug: Nab-paclitaxel

Drug: Gemcitabine