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 : Completed
First Posted : May 7, 2015
Results First Posted : November 16, 2020
Last Update Posted : November 16, 2020
|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|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||April 25, 2019|
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: Results at an overall median follow-up of 24.87 months ]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: Results at an overall median follow-up of 24.87 months ]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: Results at an overall median follow-up of 24.87 months ]This is a measure of percentage of subjects with Treatment Emergent Adverse Events Grade 3 or above collected Up to 30 days after the last participating subject discontinues study drug.
- Overall Response Rate [ Time Frame: Results at an overall median follow-up of 24.87 months ]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: Results at an overall median follow-up of 24.87 months ]
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: Results at an overall median follow-up of 24.87 months ]The CA19-9 response rate is defined as the percentage of subjects with a decline of 20%, 90%, and other thresholds considered clinically meaningful, from baseline. This is a percentage of patients with > or = 60% reduction from baseline.
- Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). [ Time Frame: Results at an overall median follow-up of 24.87 months ]Unit is month: TUDD1 defined as time interval between random & 1st occurrence of decrease in QLQ-C30 score ≥10 pts w/o improvement in QoL score of ≥10 points or any further available QoL data due to deterioration. Proportion of subjects with TEAE VTE of any grade defined by SMQ terms as "embolic and thrombotic events, venous". Proportion of subjects who met the "responder" criteria prior to initiation of subsequent anticancer therapy. Response defined as achievement of a ≥50% reduction in MPAC visual analog scale which measures pain intensity or analgesic consumption, or a ≥20-point improvement from baseline in KPS sustained for a period of ≥ 4 consecutive weeks without showing any sustained worsening from baseline in any of the other parameters OR Subject stable on all parameters (pain and KPS), & showed a marked, sustained wt gain (≥7% increase from baseline maintained for ≥4 weeks) not due to fluid accumulation.
- Rate of Venous Thromboembolic Events (VTE) [ Time Frame: Results at an overall median follow-up of 24.87 months ]The VTE rate is defined as percentage 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
|Study Director:||George Cole, MD||Pharmacyclics LLC.|