A Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer

Part of paid clinical trials in Fort Wayne, Indiana.

Sponsor
Sumitomo Pharma America, Inc.
Study ID
NCT02483247
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

  • BBI503 — DRUG
    Patients in this trial will receive BBI503 orally, daily, and continuously. The dose-level of BBI503 will be assigned according to the dose-cohort open at the time the patient enrolls into a given arm. The study-arm and combination anti-cancer agent for a given patient will be determined by the investigator. BBI503 Dose Level 1: 200 mg once daily, Dose Level 2: 300 mg once daily.
  • Capecitabine — DRUG
    Capecitabine 1000 mg/m\^2 body surface area is administered orally, twice daily, on days 1-14 of each 21 day cycle.
  • Doxorubicin — DRUG
    Doxorubicin 60 mg/m\^2 body surface area is administered intravenously once every three weeks (21-days).
  • Nivolumab — DRUG
    Nivolumab 3 mg/kg is administered as an intravenous infusion over 60 minutes on day 1 and day 15 of each 28 day cycle.
  • Pembrolizumab — DRUG
    Pembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes once every three weeks (21-days).
  • Paclitaxel — DRUG
    Paclitaxel 80 mg/m\^2 body surface area is administered intravenously once weekly on day 1, day 8, and day 15 of each 28 day cycle.
  • Sunitinib — DRUG
    Sunitinib 37.5 mg is administered once daily.

Study Details

This is an open label, multi-center, Phase 1/2 study of BBI503 administered in combination with selected anti-cancer therapeutics in adult patients with advanced cancer. The goal of the study is to determine the safety, tolerability, and RP2D of BBI503 in combination with each of the selected anti-cancer agents.

Key Dates

Start date
Sep 30, 2015
Status verified
Nov 2023
Primary completion
May 31, 2019
Completion
May 31, 2019

Study Design

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

Arms

  • Experimental: Combo with Capecitabine
  • Experimental: Combo with Doxorubicin
  • Experimental: Combo with Nivolumab (US only)
  • Experimental: Combo with Pembrolizumab
  • Experimental: Combo with Paclitaxel
  • Experimental: Combo with Sunitinib

Primary Outcome Measure

Determination of the safety and tolerability of BBI503 administered in combination with selected anti-cancer therapeutics by assessing dose-limiting toxicities (DLTs) [ Time Frame: 3 or 4 weeks based on the cycle of the selected anti-cancer therapeutics ]

Locations (6)

FacilityCityStateZIPSite coordinators
Parkview Research CenterFort WayneIndiana--
Indiana University Health GoshenGoshenIndiana46526-
Indiana University -BallIndianapolisIndiana--
Indiana University-SCCIndianapolisIndiana--
Louisiana State UnivesityNew OrleansLouisiana--
US Oncology ResearchFairfaxVirginia--

Find similar trials in Fort Wayne, IN

By research site
Parkview Research Center· Fort Wayne, INIndiana University Health Goshen· Goshen, INIndiana University -Ball· Indianapolis, INIndiana University-SCC· Indianapolis, INLouisiana State Univesity· New Orleans, LAUS Oncology Research· Fairfax, VA

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