Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Washington University School of Medicine
Study ID
NCT02546531
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Defactinib — BIOLOGICAL
  • Pembrolizumab — BIOLOGICAL
  • Gemcitabine — DRUG

Study Details

In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated reasonable anti-tumor activity in the preclinical setting. Furthermore, a maximal synergetic effect was achieved when a FAK inhibitor was given in combination with a PD-1 antagonist and chemotherapy in multiple pancreas tumor animal models. This supports the concept of using FAK inhibitors to reduce stromal fibrosis during checkpoint immunotherapeutic treatment. Therefore, these robust preclinical findings will be tested in the proposed phase I trial.

Key Dates

Start date
Feb 3, 2016
Status verified
Jul 2021
Primary completion
Nov 17, 2017
Completion
Jan 11, 2021

Study Design

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

Arms

  • Experimental: Dose escalation (defactinib, pembrolizumab, gemcitabine)
    * Defactinib is an oral drug which will be administered on an outpatient basis at the prescribed dose twice a day daily during each 21-day cycle. * Pembrolizumab is an intravenous (IV) drug which will be administered on an outpatient basis over 30 minutes (-5/+10) at a dose of 200 mg on Day 1 of each 21-day cycle. * Gemcitabine is an IV drug which will be administered on an outpatient basis over 30 minutes at the prescribed dose on Days 1 and 8 of each 21-day cycle. * Participants enrolled in Dose Level 1 and 2 will not receive gemcitabine.
  • Experimental: Dose expansion (defactinib, pembrolizumab, gemcitabine)
    * Defactinib is an oral drug which will be administered on an outpatient basis at the prescribed dose twice a day daily during each 21-day cycle. * Pembrolizumab is an intravenous (IV) drug which will be administered on an outpatient basis over 30 minutes (-5/+10) at a dose of 200 mg on Day 1 of each 21-day cycle. * Gemcitabine is an IV drug which will be administered on an outpatient basis over 30 minutes at the prescribed dose on Days 1 and 8 of each 21-day cycle. * Participants enrolled in Dose Level 1 and 2 will not receive gemcitabine.

Primary Outcome Measure

Recommended phase II dose [ Time Frame: Completion of the first cycle of all patients enrolled (approximately 25 months) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in Rochester, MN

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Mayo Clinic· Rochester, MNWashington University School of Medicine· St Louis, MO

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