Trial · NCT02436668
Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
NCT02436668, Phase 3, Completed, Pharmacyclics LLC.; results first posted 2020-11-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE). Trials, record NCT02436668. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02436668
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
- NCT number
- NCT02436668
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 430 participants, actual
- Lead sponsor
- Pharmacyclics LLC.
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Interventions
- Ibrutinib, Gemcitabine, Nab-paclitaxel
- First posted
- 2015-05-07
- Last updated
- 2020-12-30
- Results first posted
- 2020-11-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 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. |
| Primary | Overall Survival (OS) | 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. |
| 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. | 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. |
| Secondary | Overall Response Rate | Results at an overall median follow-up of 24.87 months | ORR is defined as the percentage of subjects who achieve a complete response or partial response, based on investigator assessment according to RECIST 1.1. |
| Secondary | Clinical Benefit Response | 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). |
| Secondary | Carbohydrate Antigen 19-9 (CA19-9) Response | 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. |
| Secondary | Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). | Results at an overall median follow-up of 24.87 months | Unit is the month: TUDD1 - the time between random \& 1st occurrence of a decrease in QLQ-C30 score ≥10 pts w/o improvement in QoL score of ≥10 points or any further QoL data due to deterioration. The proportion of subjects who met the "responder" criteria prior to subsequent anticancer therapy initiation. 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 weight gain (≥7% increase from baseline maintained for ≥4 weeks) not due to fluid accumulation. |
| Secondary | Rate of Venous Thromboembolic Events (VTE) | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | Results at an overall median follow-up of 24.87 months | Months | MEDIAN | |
| PRIMARY | Overall Survival (OS) | Results at an overall median follow-up of 24.87 months | Months | MEDIAN | |
| 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. | Results at an overall median follow-up of 24.87 months | The safety population included 420 subjects and was used for the analyses of all safety endpoints and included all subjects in the ITT population who received at least 1 dose of study drug (ibrutinib, placebo, nab-paclitaxel, or gemcitabine). The data sets analyzed are summarized in the following table. | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate | Results at an overall median follow-up of 24.87 months | percentage of Patients | NUMBER | |
| SECONDARY | Clinical Benefit Response | Results at an overall median follow-up of 24.87 months | Clinical benefit response rate was not analyzed due to incomplete data for the analgesic use. Data for subjects who Achieved a \>=50% reduction in pain intensity, 20-point or greater improvement in KPS (\>=4 consecutive weeks), Sustained weight gain (\>=7% increase maintained for \>=4 weeks) not due to fluid accumulationare reported. | percentage of patients | NUMBER |
| SECONDARY | Carbohydrate Antigen 19-9 (CA19-9) Response | Results at an overall median follow-up of 24.87 months | percentage of patients | NUMBER | |
| SECONDARY | Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). | Results at an overall median follow-up of 24.87 months | months | MEDIAN | |
| SECONDARY | Rate of Venous Thromboembolic Events (VTE) | Results at an overall median follow-up of 24.87 months | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Ibrutinib+Gemcitabine+Nab-paclitaxel | 5.32 | 95% Confidence Interval 3.75 to 5.49 | Months | |
| Progression Free Survival (PFS) | Placebo+Gemcitabine+Nab-Paclitaxel | 6.01 | 95% Confidence Interval 5.45 to 7.16 | Months | |
| Overall Survival (OS) | Ibrutinib+Gemcitabine+Nab-paclitaxel | 9.69 | 95% Confidence Interval 8.57 to 10.41 | Months | |
| Overall Survival (OS) | Placebo+Gemcitabine+Nab-Paclitaxel | 10.78 | 95% Confidence Interval 8.94 to 11.66 | Months | |
| 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. | Placebo+Gemcitabine+Nab-Paclitaxel | Subjects with any TEAE >= Grade 3 | 86.8 | percentage of participants | |
| 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. | Ibrutinib+Gemcitabine+Nab-paclitaxel | Subjects with any TEAE >= Grade 3 | 85.6 | percentage of participants | |
| 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. | Placebo+Gemcitabine+Nab-Paclitaxel | Subjects with ibrutinib/pbo-related TEAE >=Grade 3 | 55.7 | percentage of participants | |
| 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. | Ibrutinib+Gemcitabine+Nab-paclitaxel | Subjects with ibrutinib/pbo-related TEAE >=Grade 3 | 54.3 | percentage of participants | |
| Overall Response Rate | Placebo+Gemcitabine+Nab-Paclitaxel | 42.3 | 95% Confidence Interval 35.5 to 49.2 | percentage of Patients | |
| Overall Response Rate | Ibrutinib+Gemcitabine+Nab-paclitaxel | 29.5 | 95% Confidence Interval 23.3 to 36 | percentage of Patients |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo+Gemcitabine+Nab-Paclitaxel | 213 | |
| Overall Study | STARTED | Ibrutinib+Gemcitabine+Nab-paclitaxel | 211 | |
| Overall Study | COMPLETED | Placebo+Gemcitabine+Nab-Paclitaxel | 212 | |
| Overall Study | COMPLETED | Ibrutinib+Gemcitabine+Nab-paclitaxel | 207 | |
| Overall Study | NOT COMPLETED | Placebo+Gemcitabine+Nab-Paclitaxel | 1 | |
| Overall Study | NOT COMPLETED | Ibrutinib+Gemcitabine+Nab-paclitaxel | 4 |
Source ClinicalTrials.gov
Adverse events502
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo (Plus Nab-paclitaxel and Gemcitabine) | 95 | 212 | 309 |
| other | Anaemia | Blood and lymphatic system disorders | Ibrutinib (Plus Nab-paclitaxel and Gemcitabine) | 90 | 208 | 289 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo (Plus Nab-paclitaxel and Gemcitabine) | 55 | 212 | 208 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ibrutinib (Plus Nab-paclitaxel and Gemcitabine) | 75 | 208 | 221 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo (Plus Nab-paclitaxel and Gemcitabine) | 84 | 212 | 328 |
| other | Neutropenia | Blood and lymphatic system disorders | Ibrutinib (Plus Nab-paclitaxel and Gemcitabine) | 68 | 208 | 139 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo (Plus Nab-paclitaxel and Gemcitabine) | 18 | 212 | 61 |
| other | Leukopenia | Blood and lymphatic system disorders | Ibrutinib (Plus Nab-paclitaxel and Gemcitabine) | 15 | 208 | 19 |
| other | Vision blurred | Eye disorders | Placebo (Plus Nab-paclitaxel and Gemcitabine) | 15 | 212 | 18 |
| other | Vision blurred | Eye disorders | Ibrutinib (Plus Nab-paclitaxel and Gemcitabine) | 17 | 208 | 20 |
1 to 10 of 502Source ClinicalTrials.gov
See all 502 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Plus Nab-paclitaxel and Gemcitabine) | 188 | 212 |
| Total, all-cause mortality | Ibrutinib (Plus Nab-paclitaxel and Gemcitabine) | 189 | 208 |
| Total, other adverse events | Placebo (Plus Nab-paclitaxel and Gemcitabine) | 211 | 212 |
| Total, other adverse events | Ibrutinib (Plus Nab-paclitaxel and Gemcitabine) | 208 | 208 |
| Total, serious adverse events | Placebo (Plus Nab-paclitaxel and Gemcitabine) | 127 | 212 |
| Total, serious adverse events | Ibrutinib (Plus Nab-paclitaxel and Gemcitabine) | 112 | 208 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo (Plus Nab-paclitaxel and Gemcitabine) vs Ibrutinib (Plus Nab-paclitaxel and Gemcitabine): deaths from any cause | Trial comparisons |
| Placebo (Plus Nab-paclitaxel and Gemcitabine) vs Ibrutinib (Plus Nab-paclitaxel and Gemcitabine): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02436668
GET https://conductscience.org/api/trials/v1/NCT02436668/results?page=2