QUILT-3.010: A Study of Gemcitabine and Nab-paclitaxel With or Without NPC-1C to Treat Patients With Pancreatic Cancer
Summary
This was a Phase 1/2 multi-institution prospective open label study in which subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer who previously received treatment with chemotherapy with FOLFIRINOX or FOLFIRINOX-like regimen received the investigational agent NEO-102 (NPC-1C). The Phase 1 portion of this study evaluated the safety of NEO-102 in combination with Gemcitabine in a dose de-escalation design with a starting dose of 1.5 mg/kg/dose. If 2 of 6 patients experience DLT, the dose will be de-escalated to 1 mg/kg/dose to evaluate the safety of NEO-102 in combination with Gemcitabine. . In the Phase 2 portion patients were randomized into one of two arms: A: NPC-1C with gemcitabine and nab-paclitaxel or B: gemcitabine and nab-paclitaxel
Timeline
- Start
- 2013-04
- Primary completion
- 2017-03-13
- Completion
- 2019-12
Outcome
Missed primary endpoint
Stopped: “DSMB terminated the trial for futility.”
paper Median OS was 6.6 months (95% CI, 4.7-8.4 months) with gemcitabine plus nab-paclitaxel vs 5.0 months (95% CI, 3.3-6.5 months; P = .22) with gemcitabine plus nab-paclitaxel and NPC-1C. PMID 36602796 ↗
paper In this randomized clinical trial of advanced PDAC, NPC-1C did not enhance the efficacy of gemcitabine/nab-paclitaxel. PMID 36602796 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ENSITUXIMAB | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | ENSITUXIMAB | Monoclonal antibody | 1.5 mg/kg | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Nab-paclitaxel | Small molecule | 125 mg/m2 | Intravenous |