Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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.

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

Keywords

Metastatic Pancreatic Adenocarcinoma Adenocarcinoma Paclitaxel Gemcitabine Albumin-Bound Paclitaxel Ibrutinib Nab-paclitaxel

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • Moores UCSD Cancer Center
    La Jolla California 92093 United States
  • Cedars Sinai Medical Center
    Los Angeles California 90048 United States
  • Arizona Center for Cancer Care
    Avondale Arizona 85323 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pharmacyclics LLC.
ID
NCT02436668
Phase
Phase 2/3
Study Type
Interventional
Last Updated
February 7, 2018