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Biliary Tract CancerPhase 1/2NCT02773459

MEK162 in Combination With Capecitabine in Advanced Biliary Tract Cancer

A Phase 1/2 study testing MEK162+capecitabine in people with Biliary Tract Cancer, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Biliary Tract Cancer
What is being tested?
MEK162+capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteSouth Korea
Study dates
Apr 2016to 7 Jan 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
MEK162+capecitabine
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEK162+capecitabineDrug

    Also called MEK162, xeloda

    In phase 1 part: capecitabine(mg/m2) will be given twice a day, 2 week on/1week off Q 3weeks + MEK162 twice a day, continuously, starting at 1000mg/m2 and 30mg/m2 respectively. Expansion part will be treated with the dose found at phase 1 part.

Study groups in NCT02773459
Study groupRoleWhat they receive
Phase 1 partExperimentalto assess the maximal tolerated dose (MTD) of MEK162+Capecitabine combination
Receives: Drug: MEK162+capecitabine
Expansion partExperimentalto assess the efficacy (PFS) of MEK162+Capecitabine combination
Receives: Drug: MEK162+capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD)

    MTD in all treated population (Phase 1 part)

    Measured: 6 months

  2. Progression-free survival (PFS)

    PFS in all treated population (Expansion part)

    Measured: 3 months

Secondary outcomes (4)

  1. Dose-limiting Toxicity (DLT)

    DLT in all treated population, according to NCI-CTCAE v 4.0 (Phase 1 part)

    Measured: 6 months

  2. Recommended Phase 2 Dose (RP2D)

    RP2D to be used at Expansion part (Phase 1 part)

    Measured: 6 months

  3. Response rate

    Response rate in all treated patients (Expansion part)

    Measured: 6 months

  4. Overall survival (OS)

    OS in all treated patients

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion7 Jan 2019
  4. Study completion7 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02773459
Sponsor's protocol ID
BTC-MEK162
Status last verified
Sep 2019
First submitted
13 May 2016
Last updated
30 Sep 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Kim JW, Lee KH, Kim JW, Suh KJ, Nam AR, Bang JH, Bang YJ, Oh DY. Enhanced antitumor effect of binimetinib in combination with capecitabine for biliary tract cancer patients with mutations in the RAS/RAF/MEK/ERK pathway: phase Ib study. Br J Cancer. 2019 Aug;121(4):332-339. doi: 10.1038/s41416-019-0523-5. Epub 2019 Jul 17.

    PubMed 31312030

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MEK162+capecitabine in people with Biliary Tract Cancer, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02773459, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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