Clinical trial · Interventional
A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer
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
NCT02210559CI-TRIAL-00064413completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer (Unresectable) | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FG-3019 | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FG-3019 + Gemcitabine + Nab-paclitaxel
- 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.
- interventionNames
- Drug: FG-3019
- Drug: Gemcitabine
- Drug: Nab-paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine + Nab-paclitaxel
- 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.
- interventionNames
- Drug: Gemcitabine
- Drug: Nab-paclitaxel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.