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Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer

NCT02562898 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-05-06

Study results available
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Summary

Gemcitabine and nab-paclitaxel is a standard regimen (NCCN, Category 1) for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). However, further improvement in treatment is needed. Increasingly, the nature of the immune infiltrate in PDAC appears to be tumor promoting. In preclinical studies, ibrutinib treatment, presumably by reprogramming B cells, results in increased CD8+ T cells to assist in tumor control. Preclinical studies of ibrutinib plus gemcitabine show superior antitumor effects compared to gemcitabine alone in both orthotopic murine pancreatic cancer cell line grafts and in genetically engineered mouse models. Thus, the investigators propose a clinical trial of ibrutinib plus the standard gemcitabine based regimen of gemcitabine and nab-paclitaxel, evaluating safety, then efficacy and including correlative studies.

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Interventions

DRUG

Ibrutinib

560, 840, 420, or 280mg, orally once per day - 4 week cycle

DRUG

Paclitaxel

125mg/m2 IV Day 1, 8, and 15 - 4 week cycle

DRUG

Gemcitabine

1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle

Sponsors & Collaborators

  • Stand Up To Cancer

    collaborator OTHER

  • Lustgarten Foundation

    collaborator OTHER

  • Margaret Tempero

    lead OTHER

Principal Investigators

  • Margaret Tempero, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-12
Primary Completion
2019-11-15
Completion
2020-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02562898 on ClinicalTrials.gov