A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer

Sponsor
University Health Network, Toronto
Study ID
NCT02151084
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Biliary Tract Carcinoma
  • Gallbladder Carcinoma

Eligibility Criteria

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

Interventions

  • Selumetinib — DRUG
  • Cisplatin — DRUG
  • Gemcitabine — DRUG

Study Details

This is a phase II study (the second stage of testing a new drug or new drug combinations) to see how useful two different schedules of study drug selumetinib with cisplatin and gemcitabine are compared to cisplatin and gemticabine alone in patients with biliary cancer. Selumetinib, an oral drug which plays an important role in the regulation of cell growth (MEK 1/2 inhibitor) has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. Selumetinib has also been shown to shrink tumours when given in combination with cisplatin and gemcitabine in research studies done in animals and in some patients with biliary tract cancer. Cisplatin and gemcitabine are intravenous drugs that work by damaging DNA in tumor cells so that they are unable to grow and divide.

Key Dates

Start date
Nov 30, 2014
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
57 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Continuous Dosing)
    Run-In: Selumetinib, orally, BID for 7 days (Day -7 to Day -1) On treatment: Selumetinib, orally, BID from Day 1-21 of every 28 day cycle. Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.
  • Experimental: Arm B (Sequential Dosing)
    Run-In: Selumetinib, orally, BID for 5 days (Day -7 to Day -3) with 2 days washout On treatment: Selumetinib, orally, BID from Day 1-5 and 8-19 of every 28 day cycle. Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.
  • Experimental: Arm C (Standard Care)
    Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.

Primary Outcome Measure

Change in tumor size in millimetres [ Time Frame: 10 weeks post initiation of therapy ]

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