Phase 3
Completed N=424
Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
Source: ClinicalTrials.gov NCT02436668 ↗Enrolled (actual)
424
Serious AEs
56.9%
Results posted
Nov 2020
Primary outcomePrimary: Progression Free Survival (PFS) — 5.32; 6.01 Months — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a phase 3 study to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
5.32; 6.01 | <0.0001 sig |
| PRIMARY Overall Survival (OS) |
9.69; 10.78 | 0.3225 |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine. |
86.8; 85.6; 55.7; 54.3 | — |
| SECONDARY Overall Response Rate |
42.3; 29.5 | 0.0058 sig |
| SECONDARY Clinical Benefit Response |
25.8; 27.5; 1.4; 0; 11.7; 5.7 | — |
| SECONDARY Carbohydrate Antigen 19-9 (CA19-9) Response |
62.9; 53.6 | 0.0488 sig |
| SECONDARY Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). |
6.14; 4.21 | 0.0782 |
| SECONDARY Rate of Venous Thromboembolic Events (VTE) |
10.8; 8.1 | 0.3343 |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
- Stage IV disease diagnosed within 6 weeks of randomization
- Adequate hematologic function:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L
- Platelet count ≥100 x 109/L
- Hemoglobin ≥9 g/dL
- Adequate hepatic and renal function defined as:
- AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x ULN without liver metastases
- Alkaline phosphatase <3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present
- Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
- Estimated Creatinine Clearance ≥30 mL/min
- PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN
- KPS ≥70.
- Eastern Cooperative Oncology Group (ECOG) 0-1
Exclusion Criteria
- Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
- Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
- Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
- Major surgery within 4 weeks of first dose of study drug.
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- Treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
Data sourced from ClinicalTrials.gov (NCT02436668). 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.