An Open-Label Phase II Study of the Combination of GSK2118436 and GSK1120212 in Patients With Metastatic Melanoma Which is Refractory or Resistant to BRAF Inhibitor
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take both GSK2118436
and GSK1120212 together.
You will take 2 capsules of GSK1120212 by mouth once a day. You will take 2 capsules of
GSK2118436 by mouth 2 times every day (1 time in the morning and 1 time in the evening,
about 12 hours apart - a total of 4 capsules a day). If you experience severe side effects,
your doctor or the research team may lower the dose of the drug(s).
You should take the study drugs with about 1 cup (8 ounces) of room-temperature water. You
should not eat or drink anything besides water for at least 1 hour before and 2 hours after
you take the study drugs.
You will be given a study drug diary to record the times and doses that you take the study
drugs. You should bring the diary to each study visit.
Study Visits:
On Day 1 of Cycle 1:
- Your medical history will be recorded, including any symptoms you may be having. (if it
was not recorded in the previous 7 days)
- Your weight, vital signs, and performance status will be recorded.
- You will have a physical exam (if one was not performed in the previous 7 days).
- Blood (about 2 teaspoons) will be collected for routine tests (if this was not
performed in the previous 7 days).
- You will be asked about any drugs you may be taking, how you are feeling, and if you
have had any side effects.
- You will have a blood draw this visit for research purposes.
On Days 8 of Cycle 1:
- Your weight, vital signs, and performance status will be recorded.
- Blood (about 4 tablespoons) will be drawn for biomarker testing.
- You will be asked about any drugs or herbal supplements that you may be taking.
- You will be asked about any drugs you may be taking, how you are feeling, and if you
have had any side effects.
On Day 15 of Cycle 1:
- You will have a physical exam.
- Your weight, vital signs, and performance status will be recorded.
- You will have an ECG.
- Blood (about 2 teaspoons) will be collected for routine tests.
- Blood (about 4 tablespoons) will be drawn for biomarker testing.
- You will be asked about any drugs you may be taking, how you are feeling, and if you
have had any side effects.
On Day 1 of Cycles 2 and beyond:
- You will have a physical exam.
- Your weight, vital signs, and performance status will be recorded.
- Blood (about 2 teaspoons) will be collected for routine tests.
- You will be asked about any drugs you may be taking, how you are feeling, and if you
have had any side effects
- Blood (about 4 tablespoons) will be drawn for biomarker testing on day 1 of Cycle 2 and
4. If your disease worsens, blood (about 4 tablespoons) will also be drawn at that
time.
Every 8 weeks (2 cycles) from the time of the start of the treatment, you will have an
x-ray, a CT scan, an MRI scan, a skin exam, and/or a bone scan to check the status of the
disease.
Every 12 weeks, you will have an ECHO performed.
If at any point during the study you have any symptoms or signs of a serious skin, eye, or
heart side effect, you may be referred to a dermatologist or an ophthalmologist, or you may
have an ECG and ECHO to check your heart's health.
Length of Study:
You may continue taking the study drugs for as long as the study doctor thinks it is in your
best interest. You will no longer be able to take the study drugs if the disease gets
worse, you start having other health problems, or intolerable side effects occur.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
You will have an end-of-study visit within 4 weeks after your last dose of study drugs. The
following tests and procedures will be performed:
- You will have a physical exam.
- Your weight, vital signs, and performance status will be recorded.
- You will have an ECG.
- Blood (about 2 teaspoons) will be collected for routine tests.
- You will have an x-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI)
scan, and/or bone scan to check the status of the disease if you are taken off the
study for any other reason than the disease getting worse.
- Blood (about 4 tablespoons) will be drawn for biomarker testing.
- You will have the same kind of mandatory biopsy that you did at screening. You may be
allowed to continue receiving the study drugs until the time of this biopsy (up to 2
days) even if the disease is not showing a response to the study drugs. Your doctor
and/or the study team will discuss this with you.
This is an investigational study. Neither GSK2118436 nor GSK1120212 are FDA approved or
commercially available. They are currently being used for research purposes only.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR)
Overall response rate defined as percentage of subjects with a confirmed complete response (CR) or a partial response (PR) at any time as per RECIST 1.1 criteria.
8 weeks
No
Kevin B. Kim, MD,BA
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2011-0579
NCT01619774
September 2012
Name | Location |
---|---|
UT MD Andreson Cancer Center | Houston, Texas 77030 |