Trials / Completed
CompletedNCT02436668
Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
A Randomized, Multicenter, Double-blind, Placebo-controlled, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 430 (actual)
- Sponsor
- Pharmacyclics LLC. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ibrutinib | |
| DRUG | Gemcitabine | |
| DRUG | Nab-paclitaxel |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2018-10-01
- Completion
- 2019-04-25
- First posted
- 2015-05-07
- Last updated
- 2020-12-30
- Results posted
- 2020-11-16
Locations
86 sites across 8 countries: United States, Belgium, France, Germany, Italy, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02436668. Inclusion in this directory is not an endorsement.