A Study of MEK162 With Gemcitabine and Oxaliplatin in Biliary Cancer

February 14, 2018 updated by: University Health Network, Toronto

A Phase I Trial of MEK Inhibitor MEK 162 Combined Sequentially With Gemcitabine-Oxaliplatin (GEMOX) in Patients With Advanced Biliary Cancer

This is a phase I study (an early study to check the safety of a new drug or drug combination) to find the safest and most tolerated dose of the combination of oxaliplatin with gemcitabine and MEK 162 in patients with biliary cancer (including gallbladder cancers and cancers associated with the bile ducts leading from the gallbladder and to and from the liver) that is not curable by surgery and/or has spread beyond the biliary tree (place where cancer started). Everyone will receive the same standard doses of oxaliplatin and gemcitabine but may receive different doses of MEK 162.

MEK 162 is a new drug which plays an important role in the regulation of cell growth and has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. This type of drug 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 cancer.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histopathological or cytological diagnosis of non-resectable, recurrent or metastatic biliary tract (intra- or extra-hepatic) or gallbladder carcinoma.
  • Have measurable disease.
  • Not received prior systemic therapy for advanced biliary cancer.
  • Age 18 years of age or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  • Estimated life expectancy is greater than 3 months.
  • Have adequate hematological function.
  • Have adequate cardiac function.
  • All radiology studies performed within 4 weeks prior to the start of therapy.
  • No evidence of active uncontrolled infection.
  • Ability to understand and willing to sign a written informed consent document.
  • Ongoing prior toxicities related to previous treatments received to grade 1 or less at time of registration.
  • Able to take oral medications.

Exclusion Criteria:

  • Progressing within 6 months of receiving adjuvant treatment for biliary tract cancer.
  • Not have received prior chemotherapy for non-resectable or metastatic disease or MEK inhibitor.
  • Histopathological or cytological diagnosis of ampullary carcinoma.
  • Incomplete recovery from previous surgery.
  • Undergoing current treatment with curative intent.
  • History of prior malignancy that could interfere with the response evaluation.
  • Any evidence of severe or uncontrolled systemic diseases or laboratory findings that may affect participation in the trial.
  • Any psychiatric or other disorder likely to impact on informed consent.
  • Pregnant or nursing (lactating) women.
  • Agree to use highly effective methods of contraception throughout the study and for 6 months after study drug discontinuation.
  • Significant cardiac disease.
  • History of retinal degenerative disease.
  • History of Gilbert's syndrome.
  • Known positive serology for HIV, active hepatitis B, and/or active hepatitis C infection.
  • Neuromuscular disorders that are associated with elevated creatine kinase.
  • Planning on embarking on a new strenuous exercise regimen after first dose of study treatment.
  • Impairment of gastrointestinal function or gastrointestinal disease.
  • Any other condition that would contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MEK 162, gemcitabine, and oxaliplatin
MEK 162 (30 mg or 45 mg by mouth), twice a day, every day. Gemcitabine (1000 mg/m2 by vein), followed by oxaliplatin (85 mg/m2 by vein) every 2 weeks.
Drug: Gemcitabine
Other Names:
  • Gemzar
Drug: Oxaliplatin
Other Names:
  • Eloxatin
Drug: MEK 162

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total incidence of grade 3 and 4 adverse events
Time Frame: 2 years
2 years
Total rate of grade 3 and 4 adverse events
Time Frame: 2 years
2 years
Maximum dose level at which 0/3 patients or 1/6 patients experience dose-limiting toxicity
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with objective response rate
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Jennifer Knox, M.D., Princess Margaret Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Biliary GEMOX / MEK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gallbladder Carcinoma

Clinical Trials on Gemcitabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe