A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers

Part of paid clinical trials in Denver, Colorado.

Sponsor
Sumitomo Pharma America, Inc.
Study ID
NCT02467361
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

  • BBI608 — DRUG
    Patients in this trial will receive BBI608 at assigned dose-levels according to the study arm the patient is enrolled into. BBI608 Dose Level 1: 240 mg twice daily, Dose Level 2: 480 mg twice daily. The assigned dose of BBI608 will be administered twice daily with approximately 12 hours between doses.
  • Ipilimumab — DRUG
    Ipilimumab 3 mg/kg is administered intravenously over 90 minutes every 21 days for a total of 4 doses.
  • Nivolumab — DRUG
    Nivolumab 3 mg/kg is administered as an intravenous infusion over 60 minutes every 14 days.
  • Pembrolizumab — DRUG
    Pembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes once every 21 days.

Study Details

This is an open label, multi-center, Phase 1/2 study of BBI608 administered in combination with immunotherapy in adult patients with advanced cancers. The goal of the study is to determine the RP2D of BBI608 in combination with each of the immunotherapeutic agents.

Key Dates

Start date
Aug 31, 2015
Status verified
Nov 2023
Primary completion
Jan 29, 2021
Completion
Jan 29, 2021

Study Design

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

Arms

  • Experimental: Combo with Ipilimumab
  • Experimental: Combo with Nivolumab
  • Experimental: Combo with Pembrolizumab

Primary Outcome Measure

Determination of the safety and tolerability of BBI608 administered in combination with selected immunotherapeutic agent by assessing dose-limiting toxicities (DLTs) [ Time Frame: 6 weeks ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterDenverColorado80045-
Emory University Winship Cancer InstituteAtlantaGeorgia30322-
University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Weill Cornell Medical CollegeNew YorkNew York10065-
Institute for Translational Oncology ResearchGreenvilleSouth Carolina29605-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Denver, CO

By research site
University of Colorado Cancer Center· Denver, COEmory University Winship Cancer Institute· Atlanta, GAUniversity of Chicago Medicine Comprehensive Cancer Center· Chicago, ILDana Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MAWeill Cornell Medical College· New York, NY

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