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Completed

NCT Number: 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)

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.

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Key information

Conditions

Metastatic Pancreatic Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cliniques Universitaires Saint-Luc, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ibrutinib

Drug

Other names: IMBRUVICA®

Gemcitabine

Drug

Nab-paclitaxel

Drug

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. Overall Response Rate

    Time frame: 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.

  3. 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).

  4. 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.

  5. 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 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Pharmacyclics LLC.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
May 7, 2015
Registry last updated
Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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