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

NCT02151084 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: BIL-MEK
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Biliary Tract Carcinoma; Gallbladder Carcinoma

Keywords

randomized; selumetinib; tablets; cisplatin; gemcitabine; non-resectable; recurrent; metstatic

Outcome Measures

Primary Outcomes (1)

• Change in tumor size in millimetres

  Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  10 weeks post initiation of therapy

Secondary Outcomes (6)

• Number of participants with objective response and/or stable disease

  6 months post initiation of therapy

• Percentage of patients without progressive disease

  10 weeks post initiation of therapy

• Progression-free survival in months

  Enrollment to disease progression or death

• Overall survival in months

  Time from enrollment to date of death

• Total incidence of adverse events

  2 years

Study Arms (3)

Arm A (Continuous Dosing)

EXPERIMENTAL

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.

Drug: Selumetinib; Drug: Cisplatin; Drug: Gemcitabine

Arm B (Sequential Dosing)

EXPERIMENTAL

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.

Drug: Selumetinib; Drug: Cisplatin; Drug: Gemcitabine

Arm C (Standard Care)

EXPERIMENTAL

Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.

Drug: Cisplatin; Drug: Gemcitabine

Interventions

Selumetinib DRUG

Also known as: AZD6244

Arm A (Continuous Dosing); Arm B (Sequential Dosing)

Cisplatin DRUG

Also known as: Platinol

Arm A (Continuous Dosing); Arm B (Sequential Dosing); Arm C (Standard Care)

Gemcitabine DRUG

Also known as: Gemzar

Arm A (Continuous Dosing); Arm B (Sequential Dosing); Arm C (Standard Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unresectable, recurrent or metastatic, measurable biliary tract cancer or gall bladder cancer
• No prior systemic therapy
• Performance status 0, 1, or 2
• Age 18 years or older
• Estimated life expectancy \> 3 months
• Adequate hematological, liver, renal function
• No evidence of active uncontrolled infection
• Capable of giving written consent
• Acceptable recovery of previous side effects

You may not qualify if:

• Progressing within 3 or 6 months of receiving certain treatments
• Prior chemotherapy for non-resectable or metastatic disease or a MEK inhibitor
• Progressing within 6 months of adjuvant treatment.
• May not have received prior chemotherapy for non-resectable/metastatic disease.
• Prior MEK, RAS, or RAF inhibitors or history of hypersensitivity to study drugs.
• Ampullary carcinoma
• Incomplete recovery from previous surgery
• Undergoing treatment with curative intent
• Prior malignancy that could interfere with the response evaluation
• Severe or uncontrolled systemic diseases or lab finding that makes it undesirable for patient to participate
• Any psychiatric or other disorder likely to impact consent
• Pregnant or breastfeeding
• Patients with significant cardiac-related issues
• History of eye-related issues.
• Systemic disease, active infection, bleeding diatheses or renal transplant, including hep B, hep C or HIV

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Gallbladder Neoplasms; Recurrence

Interventions

AZD 6244; Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jennifer Knox, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CA (1)