Pan FGFR Kinase Inhibitor BGJ398 and Combination Chemotherapy in Treating Patients With Untreated Metastatic Pancreatic Cancer

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT02575508
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Colon Adenocarcinoma
  • Metastatic Pancreatic Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Rectal Adenocarcinoma
  • Stage III Pancreatic Cancer
  • Stage IIIA Colon Cancer
  • Stage IIIA Rectal Cancer
  • Stage IIIB Colon Cancer
  • Stage IIIB Rectal Cancer
  • Stage IIIC Colon Cancer
  • Stage IIIC Rectal Cancer
  • Stage IV Pancreatic Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer

Eligibility Criteria

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

Interventions

  • Fluorouracil — DRUG
    Given IV
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Oxaliplatin — DRUG
    Given IV
  • pan FGFR Kinase Inhibitor BGJ398 — DRUG
    Given IV
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This phase Ib/II trial studies the side effects and best dose of pan fibroblast growth factor receptor (FGFR) kinase inhibitor BGJ398 when given together with fluorouracil, irinotecan hydrochloride and oxaliplatin (combination chemotherapy) in treating patients with untreated pancreatic cancer that has spread to another place in the body. Pan FGFR kinase inhibitor BGJ398 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pan FGFR kinase inhibitor BGJ398 together with fluorouracil, irinotecan hydrochloride and oxaliplatin may be a better treatment for pancreatic cancer.

Key Dates

Status verified
May 2016
Primary completion
May 31, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (oxaliplatin, irinotecan, fluorouracil, BGJ398)
    Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously over 46 hours on days 1 and 15. Patients also receive pan FGFR kinase inhibitor BGJ398 PO QD on days 8-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of dose-limiting toxicity (DLT) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase Ib) [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263-

Find similar trials in Buffalo, NY

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Roswell Park Cancer Institute· Buffalo, NY

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