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Trial record 1 of 1 for:    PCYC-1137-CA
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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 : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics LLC.

Brief Summary:
This is a phase 2/3 to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Adenocarcinoma Drug: Ibrutinib Drug: Gemcitabine Drug: Nab-paclitaxel Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 429 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Phase 2/3 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 : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Ibrutinib

Ibrutinib daily in combination with:

Nab-paclitaxel and gemcitabine

Drug: Ibrutinib
Other Name: IMBRUVICA®
Drug: Gemcitabine Drug: Nab-paclitaxel
Placebo Comparator: Placebo

Placebo daily in combination with:

Nab-paclitaxel and gemcitabine

Drug: Gemcitabine Drug: Nab-paclitaxel



Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Approximately 3 years after the first subject is randomized. ]

Secondary Outcome Measures :
  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: Up tp 30 days after the last participating subject discontinues study drug ]
  2. Overall Survival (OS) [ Time Frame: Three years after first subject enrolled ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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).
  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  • Major surgery within 4 weeks of first dose of study drug.
  • Treatment with a strong cytochrome P450 (CYP) 3A inhibitor.

Information from the National Library of Medicine

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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Sponsors and Collaborators
Pharmacyclics LLC.
Investigators
Study Director: George Cole, MD Pharmacyclics LLC.

Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT02436668     History of Changes
Other Study ID Numbers: PCYC-1137-CA
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: April 2017

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs