NCT02346032

Brief Summary

Phase II Study of Refametinib, a MEK inhibitor, as second-line treatment in advanced biliary tract adenocarcinoma

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

June 30, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2016

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

November 18, 2014

Last Update Submit

April 24, 2017

Conditions

Biliary Tract Cancer

Keywords

second line

Outcome Measures

Primary Outcomes (1)

  • Response rate

    the rate of complete response and partial response among all evaluable patients

    12months

Secondary Outcomes (5)

  • adverse events in each cycle were documented based on CTCAE v 4.03

    24months

  • Duration of response

    12months

  • Progression-free survival

    6months

  • Exploratory correlative analysis

    15 days

  • Overall survival

    12months

Study Arms (1)

refametinib

EXPERIMENTAL

refametinib medication

Drug: refametinib

Interventions

refametinibDRUG

Refametinib will be administered orally at the starting dose of 50 mg twice daily on a continuous daily dosing schedule.

refametinib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18
  • histologically or cytologically confirmed adenocarcinoma of biliary tract
  • unresectable or metastatic
  • ECOG performance status of 0\~2
  • measurable lesion per RECIST 1.1 criteria
  • adequate marrow, hepatic, renal functions
  • normal range of cardiac function confirmed by echocardiogram within 1 year (LVEF ≥50)
  • Child-Pugh Class A in case of liver cirrhosis
  • One prior treatment of cytotoxic chemotherapy (including adjuvant treatment within 12 months)
  • Resolution of all acute toxic effects of any prior therapy to Common Toxicity Criteria for Adverse Events (CTCAE 4.03) ≤ grade 1.
  • provision of a signed written informed consent

You may not qualify if:

  • History of cardiac disease
  • Ongoing infection \> Grade 2 according to NCI-CTCAE version 4.03. Hepatitis B is allowed if no active replication (defined as abnormal ALT \>2xULN associated with HBV DNA \>20,000 IU/mL) is present
  • Severe co-morbid illness and/or active infections including active hepatitis C and human immunodeficiency virus (HIV) infection
  • History of interstitial lung disease (ILD).
  • Any cancer curatively treated \< 3 years prior to study entry, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Staging: Ta, Tis and T1).
  • Renal failure requiring hemo- or peritoneal dialysis.
  • Clinically significant GI bleeding (CTCAE 4.03 grade 3 or higher) within 30 days prior to start of screening
  • Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months prior to start of screening.
  • History of organ allograft, cornea transplantation will be allowed
  • Active CNS metastases not controllable with radiotherapy or corticosteroids
  • Visible retinal pathology as assessed by ophthalmologic exam that is considered a risk factor for RVO or CSR.
  • Known history of hypersensitivity to study drugs
  • Any condition that was unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  • Non-healing wound, ulcer, or bone fracture.
  • Patients with seizure disorder requiring medication.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

N-(3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-6-methoxyphenyl)-1-(2,3-dihydroxypropyl)cyclopropane-1-sulfonamide

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D, Devision of hematology-oncology, Department of medicine

Study Record Dates

First Submitted

November 18, 2014

First Posted

January 26, 2015

Study Start

June 30, 2015

Primary Completion

September 30, 2016

Study Completion

October 13, 2016

Last Updated

April 26, 2017

Record last verified: 2017-04