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

Primary Purpose

Biliary Tract Carcinoma, Gallbladder Carcinoma

Status

Active

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Selumetinib

Cisplatin

Gemcitabine

About this trial

This is an interventional treatment trial for Biliary Tract Carcinoma focused on measuring randomized, selumetinib, tablets, cisplatin, gemcitabine, non-resectable, recurrent, metstatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm A (Continuous Dosing)

Arm B (Sequential Dosing)

Arm C (Standard Care)

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Change in tumor size in millimetres

Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Secondary Outcome Measures

Number of participants with objective response and/or stable disease

Percentage of patients without progressive disease

Progression-free survival in months

Overall survival in months

Total incidence of adverse events

Total rate of grade 3 and 4 toxicities

Full Information

NCT ID

NCT02151084

First Posted

May 28, 2014

Last Updated

June 15, 2023

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT02151084

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 2014 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Tract Carcinoma, Gallbladder Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A (Continuous Dosing)

Arm Type

Experimental

Arm Description

Arm Title

Arm B (Sequential Dosing)

Arm Type

Experimental

Arm Description

Arm Title

Arm C (Standard Care)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Selumetinib

Other Intervention Name(s)

AZD6244

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Platinol

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Primary Outcome Measure Information:

Title

Change in tumor size in millimetres

Description

Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Time Frame

10 weeks post initiation of therapy

Secondary Outcome Measure Information:

Title

Number of participants with objective response and/or stable disease

Time Frame

6 months post initiation of therapy

Title

Percentage of patients without progressive disease

Time Frame

10 weeks post initiation of therapy

Title

Progression-free survival in months

Time Frame

Enrollment to disease progression or death

Title

Overall survival in months

Time Frame

Time from enrollment to date of death

Title

Total incidence of adverse events

Time Frame

2 years

Title

Total rate of grade 3 and 4 toxicities

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Knox, M.D.

Organizational Affiliation

Princess Margaret Cancer Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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