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A Study of MEK162 With Gemcitabine and Oxaliplatin in Biliary Cancer

NCT02105350 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-02-19

No results posted yet for this study

Summary

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.

Conditions

  • Biliary Tract Carcinoma
  • Gallbladder Carcinoma

Interventions

DRUG

MEK 162

DRUG

Gemcitabine

DRUG

Oxaliplatin

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Jennifer Knox, M.D. · Princess Margaret Cancer Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02105350 on ClinicalTrials.gov