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 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.

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

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

  1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
  2. Stage IV disease diagnosed within 6 weeks of randomization
  3. Adequate hematologic function:
  4. Absolute neutrophil count (ANC) ≥1.5 x 109/L
  5. Platelet count ≥100 x 109/L
  6. Hemoglobin ≥9 g/dL
  7. Adequate hepatic and renal function defined as:
  8. AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x ULN without liver metastases
  9. Alkaline phosphatase <3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present
  10. Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
  11. Estimated Creatinine Clearance ≥30 mL/min
  12. PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN
  13. KPS ≥70.
  14. Eastern Cooperative Oncology Group (ECOG) 0-1

You CAN'T join if...

  1. Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
  2. Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
  3. Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
  4. Major surgery within 4 weeks of first dose of study drug.
  5. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  6. 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

Details

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