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

Part of paid clinical trials in San Francisco, California.

Sponsor
Margaret Tempero
Study ID
NCT02562898
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    560, 840, 420, or 280mg, orally once per day - 4 week cycle
  • Paclitaxel — DRUG
    125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
  • Gemcitabine — DRUG
    1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle

Study Details

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.

Key Dates

Start date
Oct 12, 2015
Status verified
Apr 2021
Primary completion
Nov 15, 2019
Completion
Sep 1, 2020

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation for safety and toxicity
    All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
  • Experimental: Immune Response cohort
    Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.

Primary Outcome Measure

Number of Patients Who Experienced a Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158-
Oregon Health and Science UniversityPortlandOregon97239-

Find similar trials in San Francisco, CA

By research site
University of California, San Francisco· San Francisco, CAOregon Health and Science University· Portland, OR

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