Phase 2
Completed N=37
A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer
Pancreatic Cancer (Unresectable)
Source: ClinicalTrials.gov NCT02210559 ↗
Enrolled (actual)
37
Serious AEs
40.5%
Results posted
Mar 2023
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 24; 12; 9; 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
24; 12; 9; 6 | — |
| PRIMARY Number of Participants Who Had Surgical Complications Post-Resection |
0; 0 | — |
| SECONDARY Number of Participants Who Became Eligible for Surgery |
17; 2 | — |
| SECONDARY Number of Participants in Whom R0 Resection Was Achieved |
4; 1 | — |
| SECONDARY Number of Participants in Whom R0 or R1 Resection Was Achieved |
8; 1 | — |
| SECONDARY Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) |
5; 3 | — |
| SECONDARY Median Overall Survival |
19.38; 23.47 | — |
| SECONDARY Median Progression-Free Survival |
14.11; 11.63 | — |
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
Data sourced from ClinicalTrials.gov (NCT02210559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.