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A Study of MEK162 With Gemcitabine and Oxaliplatin in Biliary Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02105350
Recruitment Status : Withdrawn (Study was never initiated)
First Posted : April 7, 2014
Last Update Posted : February 16, 2018
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
Biliary Tract Carcinoma Gallbladder Carcinoma Drug: MEK 162 Drug: Gemcitabine Drug: Oxaliplatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of MEK Inhibitor MEK 162 Combined Sequentially With Gemcitabine-Oxaliplatin (GEMOX) in Patients With Advanced Biliary Cancer
Actual Study Start Date : June 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

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: MEK 162
Drug: Gemcitabine
Other Name: Gemzar

Drug: Oxaliplatin
Other Name: Eloxatin

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

Secondary Outcome Measures :
  1. Number of patients with objective response rate [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02105350

Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Jennifer Knox, M.D. Princess Margaret Cancer Centre

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Responsible Party: University Health Network, Toronto Identifier: NCT02105350     History of Changes
Other Study ID Numbers: Biliary GEMOX / MEK
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Keywords provided by University Health Network, Toronto:
Recurrent or metastatic
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs