Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
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|ClinicalTrials.gov Identifier: NCT02436668|
Recruitment Status : Active, not recruiting
First Posted : May 7, 2015
Last Update Posted : July 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Adenocarcinoma||Drug: Ibrutinib Drug: Gemcitabine Drug: Nab-paclitaxel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||430 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
Active Comparator: Ibrutinib
Ibrutinib daily in combination with:
Nab-paclitaxel and gemcitabine
Other Name: IMBRUVICA®
Placebo Comparator: Placebo
Placebo daily in combination with:
Nab-paclitaxel and gemcitabine
- Progression Free Survival (PFS) [ Time Frame: Approximately 3 years after the first subject is randomized. ]PFS is defined as the time from the date of randomization until disease progression per RECIST 1.1 criteria assessed by investigator, or death from any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Approximately 3 years after the first subject is randomized. ]OS, is defined as the time from date of randomization until date of death from any cause.
- 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. [ Time Frame: Up tp 30 days after the last participating subject discontinues study drug ]
- Overall response rate [ Time Frame: Approximately 3 years after the first subject is randomized. ]ORR is defined as the proportion of subjects who achieve a complete response or partial response, based on investigator assessment according to RECIST 1.1.
- Clinical Benefit Response [ Time Frame: Approximately 3 years after the first subject is randomized. ]
Subject achieved a ≥50% reduction in pain intensity (Memorial Pain Assessment Card [MPAC]) or analgesic consumption, or a 20-point or greater improvement in KPS for a period of at least 4 consecutive weeks, without showing any sustained worsening in other parameters.
OR Subject was stable on all of the aforementioned parameters, and showed a marked, sustained weight gain (≥7% increase maintained for ≥4 weeks) not due to fluid accumulation (Burris 1997).
- Carbohydrate Antigen 19-9 (CA19-9) Response [ Time Frame: Approximately 3 years after the first subject is randomized. ]CA19-9 response rate is defined as the proportion of subjects with a decline of 20%, 90% and other thresholds considered clinically meaningful, from baseline.
- Patient-reported outcomes (PRO): global health status based on QLQ-C30 [ Time Frame: Approximately 3 years after the first subject is randomized. ]Scores and change from baseline for EORTC QLQ-C30 will be descriptively summarized by treatment group and visit.
- Rate of venous thromboembolic events (VTE) [ Time Frame: Approximately 3 years after the first subject is randomized. ]The VTE rate is defined as proportion of subjects with Venous thromboembolic events (SMQ) per investigator assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436668
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|Study Director:||George Cole, MD||Pharmacyclics LLC.|