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

Biliary Tract Carcinoma Clinical Trial

Official title:

A Randomized Phase II Trial of MEK Inhibitor Selumetinib (AZD6244) Combined Continuously or Sequentially With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Patients With Advanced Biliary Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02151084
• Other study ID #: BIL-MEK
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 2014
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Receiving potent inhibitors or inducers of CYP3A4/5, CYP2C19 and CYP1A2 can continue with caution

Related Conditions & MeSH terms

• Biliary Tract Carcinoma
• Carcinoma
• Gallbladder Carcinoma

Intervention

Drug:
• Selumetinib

• Cisplatin

• Gemcitabine

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tumor size in millimetres	Response Evaluation Criteria in Solid Tumors (RECIST 1.1)	10 weeks post initiation of therapy
Secondary	Number of participants with objective response and/or stable disease		6 months post initiation of therapy
Secondary	Percentage of patients without progressive disease		10 weeks post initiation of therapy
Secondary	Progression-free survival in months		Enrollment to disease progression or death
Secondary	Overall survival in months		Time from enrollment to date of death
Secondary	Total incidence of adverse events		2 years
Secondary	Total rate of grade 3 and 4 toxicities		2 years