Biliary Tract CancerPhase 2NCT02346032
Phase II Study of Refametinib, a MEK Inhibitor, as Second-line Treatment in Advanced Biliary Tract Adenocarcinoma
A Phase 2 study testing refametinib in people with Biliary Tract Cancer, run by Samsung Medical Center.
Trial summary
Phase II Study of Refametinib, a MEK inhibitor, as second-line treatment in advanced biliary tract adenocarcinoma 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?
- refametinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2015to 13 Oct 2016
- Phase
- Phase 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
- 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
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- 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
Who cannot join
- 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.
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- 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.
- Use of strong inhibitors of CYP3A4 and strong inducers of CYP3A4 should be stopped 2 weeks before start of screening (see Appendix 1).
- Acute steroid therapy or taper for any purpose (chronic steroid therapy is acceptable provided that the dose is stable for 1 month before start of screening and thereafter).
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Pregnant or lactating women. Women of childbearing potential not employing adequate contraception. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to start of study treatment and a negative result must be documented before first dose of study drug.
About this study
Phase II Study of Refametinib, a MEK inhibitor, as second-line treatment in advanced biliary tract adenocarcinoma
Read the detailed description
Refametinib will be administered orally at the starting dose of 50 mg twice daily on a continuous daily dosing schedule.
Self-administration of refametinib tablets will take place on an outpatient basis. Patients experiencing dose-limiting toxicity attributed to study medication should have at least 1-week treatment breaks inserted into the continuous daily dosing period as needed and/or may be interrupted or reduced depending on individual tolerability.
- Conditions
- Biliary Tract Cancer
- Being tested
- refametinib
- Keywords
- second line
- 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.
refametinibDrug
Refametinib will be administered orally at the starting dose of 50 mg twice daily on a continuous daily dosing schedule.
| Study group | Role | What they receive |
|---|---|---|
| refametinib | Experimental | refametinib medication Receives: Drug: refametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
the rate of complete response and partial response among all evaluable patients
Measured: 12months
Secondary outcomes (5)
adverse events in each cycle were documented based on CTCAE v 4.03
Measured: 24months
Duration of response
median time from response to progression
Measured: 12months
Progression-free survival
Measured: 6months
Exploratory correlative analysis
KRAS/PIK3CA mutation testing using BEAMing assay will be planned
Measured: 15 days
Overall survival
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start30 Jun 2015
- Primary completion30 Sep 2016
- Study completion13 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Yeong Lim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346032
- Sponsor's protocol ID
- 2014-07-148
- Status last verified
- Apr 2017
- First submitted
- 18 Nov 2014
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Refametinib, a MEK Inhibitor, as Second-line Treatment in Advanced Biliary Tract Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02346032
- Acronym / sponsor ID
- 2014-07-148
- Conditions
- Biliary Tract Cancer
- Keywords
- second line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 13 Oct 2016 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II Study of Refametinib, a MEK inhibitor, as second-line treatment in advanced biliary tract adenocarcinoma
Detailed description
Refametinib will be administered orally at the starting dose of 50 mg twice daily on a continuous daily dosing schedule.
Self-administration of refametinib tablets will take place on an outpatient basis. Patients experiencing dose-limiting toxicity attributed to study medication should have at least 1-week treatment breaks inserted into the continuous daily dosing period as needed and/or may be interrupted or reduced depending on individual tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| refametinib | Experimental | Drug: refametinibrefametinib medication |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| refametinibRefametinib will be administered orally at the starting dose of 50 mg twice daily on a continuous daily dosing schedule. | Drug | refametinib |
Primary outcome
Response rate
Time frame: 12months
the rate of complete response and partial response among all evaluable patients
5 secondary outcomes
adverse events in each cycle were documented based on CTCAE v 4.03
Time frame: 24months
Duration of response
Time frame: 12months
Progression-free survival
Time frame: 6months
Exploratory correlative analysis
Time frame: 15 days
Overall survival
Time frame: 12months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing refametinib in people with Biliary Tract Cancer, run by Samsung Medical Center.
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 11 inclusion and 19 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 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
Response rate (time frame: 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2017.