MEK162 in Combination With Capecitabine in Advanced Biliary Tract Cancer

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Brief Title

MEK162 in Combination With Capecitabine in Advanced Biliary Tract Cancer

Official Title

Phase Ib Study of MEK162 in Combination With Capecitabine in Gemcitabine-pretreated Advanced Biliary Tract Cancer

Brief Summary

      This study is to test the efficacy of MEK162 plus capecitabine in gemcitabine-pretreated
      advanced biliary tract cancer, and to explore the predictive biomarkers for future
      large-scale clinical trials using this combination.
    

Detailed Description

      Biliary tract cancer is one of rare cancers, which is relatively more frequent in east Asia.
      The frequency of KRAS mutation and/or BRAF mutation is reported at 40 to 60%. The prognosis
      is still very poor, with only limited treatment options. The most commonly used 1st-line
      chemotherapy is gemcitabine+cisplatin combination. In gemcitabine-pretreated advanced biliary
      tract cancer, fluoropyrimidine-based chemotherapy is used. However, the overall survival with
      these cytotoxic chemotherapies is still only about 8-10 months, calling for urgent
      development of efficient treatment options.

      Recently, mitogen-activated extracellular signal regulated kinase kinase (MEK) inhibition was
      shown to have antitumor effects in KRAS mutated biliary tract cancers in preclinical model.
      In phase II study of MEK inhibitor (selumetinib) in metastatic biliary tract cancers,
      selumetinib displayed interesting activity and acceptable tolerability.

      MEK162 is an oral, highly selective MEK inhibitor. It was shown to promote apoptosis and in
      vivo antitumor activity against human biliary tract cancer cell lines. So far, there has been
      no study to test the MEK inhibitor mainly in gemcitabine-pretreated advanced biliary tract
      cancer, especially in combination of capecitabine chemotherapy.

      The aim of this study is to test the efficacy of MEK162 plus capecitabine in
      gemcitabine-pretreated advanced biliary tract cancer, and to explore the predictive
      biomarkers for future large-scale clinical trials using this combination.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Maximum tolerated dose (MTD)

Secondary Outcome

 Dose-limiting Toxicity (DLT)

Condition

Biliary Tract Cancer

Intervention

MEK162+capecitabine

Study Arms / Comparison Groups

 Phase 1 part
Description:  to assess the maximal tolerated dose (MTD) of MEK162+Capecitabine combination

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

31

Start Date

April 2016

Completion Date

January 7, 2019

Primary Completion Date

January 7, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically / cytologically verified, non-resectable, recurrent, or metastatic
             biliary tract carcinoma including intrahepatic cholangiocarcinoma, extrahepatic
             cholangiocarcinoma and gallbladder carcinoma

          -  Patients who have previously treated with gemcitabine-based chemotherapy (Prior
             treatment regimen up to 2 is allowed)

          -  Patients must have measurable or evaluable disease by RECIST 1.1

          -  Eastern Eastern Cooperative Oncology Group (ECOG) performance status: 0, 1

          -  Age ≥ 20 years

          -  Adequate bone marrow function defined as: Hb ≥ 8 g/dl, absolute neutrophil count (ANC)
             ≥ 1500/microliter (mcL), Platelets ≥ 100 x10^3/mcL

          -  Adequate renal function defined as serum creatinine < 1.6 mg/dl and/or measured
             creatinine clearance from 24-hour urine collection of ≥ 60 ml/min

          -  Adequate hepatic function defined as total bilirubin ≤ 2 mg/dl, alanine
             aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 x upper limit of normal
             (ULN)

          -  Patients with biliary obstruction can join if bilirubin corrects to required limit
             after adequate biliary drainage

          -  Women of childbearing potential must have a negative pregnancy test within 7 days
             prior to study treatment

          -  Men and women of childbearing potential must be willing to consent to using effective
             contraception while on treatment and for at least 3 months thereafter

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Evidence of another active cancer that may influence patient outcome, except for
             nonmelanoma skin carcinoma, melanoma in-situ, in-situ carcinoma of the cervix
             curatively treated, treated superficial bladder cancer, and adenocarcinoma of the
             prostate that has been surgically treated with a post-treatment prostate surface
             antigen (PSA) that is non-detectable

          -  Known brain metastases or primary central nervous system tumors with seizures that are
             not well controlled with standard medical therapy

          -  Uncontrolled intercurrent illness including, but not limited to psychiatric
             illness/social situations that would limit compliance with study requirements

          -  Known HIV positive patient

          -  Significant cardiovascular disease including congestive heart failure (New York Heart
             Association Class II or higher) or active angina pectoris

          -  Uncontrolled diabetes mellitus

          -  History of a myocardial infarction within 6 months

          -  History of a stroke or transient ischemic attack within 6 months

          -  Clinically significant peripheral vascular disease

          -  Major surgical procedure within 4 weeks

          -  Uncontrolled infection

          -  Known or suspected allergy to capecitabine

          -  Pregnant (positive pregnancy test)

          -  Breast-feeding should be discontinued if a nursing mother is to be treated on clinical
             trial

          -  Any condition that impairs patient's ability to swallow whole pills

          -  Malabsorption problem that may limit or inhibit the absorption of MEK162

          -  History of any organ or bone marrow transplant
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Do-Youn Oh, MD, PhD, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT02773459

Organization ID

BTC-MEK162


Responsible Party

Sponsor

Study Sponsor

Seoul National University Hospital


Study Sponsor

Do-Youn Oh, MD, PhD, Principal Investigator, Seoul National University Hospital


Verification Date

September 2019