A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Sumitomo Pharma America, Inc.
Study ID
NCT02231723
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

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

Interventions

  • BBI608 — DRUG
    Administered continuously twice daily with doses separated by 12 hours
  • Nab-paclitaxel — DRUG
    Nab-paclitaxel 125 mg/m\^2 I.V. infusion on Days 1, 8, and 15 of every 28-day cycle
  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m\^2 I.V. infusion on Days 1, 8, and 15 of every 28-day cycle
  • Oxaliplatin — DRUG
    Oxaliplatin 85 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle
  • Leucovorin — DRUG
    Arm C, D: Leucovorin 400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle
  • Irinotecan — DRUG
    Arm B: Irinotecan 165 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle, Arm C: Irinotecan 165 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle
  • Fluorouracil — DRUG
    Arm B, D: Fluorouracil 2400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle, Arm C: Fluorouracil 400 mg/m\^2 I.V. bolus followed by 2400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle
  • MM-398 — DRUG
    MM-398 70 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

Study Details

This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin.

Key Dates

Start date
Aug 31, 2014
Status verified
Apr 2022
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020

Study Design

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

Arms

  • Experimental: A: BBI608 in combination with Gemcitabine and nab-Paclitaxel
  • Experimental: B: BBI608 in combination with modified FOLFIRINOX
  • Experimental: C: BBI608 in combination with FOLFIRI
  • Experimental: D: BBI608 in combination with MM-398, 5-FU and leucovorin

Primary Outcome Measure

Safety by reporting the adverse events and serious adverse events [ Time Frame: 6 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054-
Emory University Winship Cancer InstituteAtlantaGeorgia30322-
Parkview Research CenterFort WayneIndiana46845-
Indiana University Health Goshen Center for Cancer CareGoshenIndiana46526-
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Comprehensive Cancer Centers of NevadaHendersonNevada89014-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
The University of Tennessee Medical CenterKnoxvilleTennessee37920-
Texas Oncology - Austin MidtownAustinTexas78705-
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
Texas Oncology - SAT&BCSan AntonioTexas78216-
Virginia Oncology AssociatesNorfolkVirginia23502-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Arizona· Phoenix, AZEmory University Winship Cancer Institute· Atlanta, GAParkview Research Center· Fort Wayne, INIndiana University Health Goshen Center for Cancer Care· Goshen, INIndiana University Melvin and Bren Simon Cancer Center· Indianapolis, INComprehensive Cancer Centers of Nevada· Henderson, NV

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