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Vemurafenib + Cobimetinib for Craniopharyngioma
Study Summary
This trial tests vemurafenib and cobimetinib to treat patients with a certain type of brain tumor. The drugs may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I don't have a history of prolonged QT syndrome.My kidney function is normal or only slightly reduced.I am in Cohort A and have only had surgery, or I am in Cohort B and have had radiation therapy.I have recovered from radiation side effects, except for hair loss or tiredness.It has been at least 21 days since my surgery.I haven't had eye inflammation in the last 4 weeks.I have no history of serious eye conditions in the past year.I am not taking, and have not taken for the last 14 days, any strong medication that affects liver enzymes.I have stopped taking any CYP1A2 substrate medication for at least 14 days.My brain tumor is confirmed to be papillary craniopharyngioma with a specific BRAF mutation.My cancer has grown by 25% in the last 13 months after surgery or radiation (for cohort B).I am not pregnant or breastfeeding, and if capable of bearing children, I have a recent negative pregnancy test.I have been on stable blood thinner medication for 4 weeks after a clotting event.I haven't had serious heart failure symptoms in the last 6 months.I do not have unstable chest pain or uncontrolled heart rhythm problems.My blood pressure is controlled and below 150/95 even with medication.I haven't had irregular heartbeats in the last 6 months.I haven't had any unusual bleeding or coughing up blood in the last 8 weeks.My steroid dose has been the same for at least 4 days.My cancer can be measured and is visible on an MRI scan.I have not been treated with BRAF or MEK inhibitors.I do not have a history of chronic lung disease.I have a diagnosis of papillary craniopharyngioma with tissue slides for review.I can take care of myself but might not be able to do heavy physical work.
- Group 1: Treatment (vemurafenib, cobimetinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you elaborate on other research projects in the field of Quality-of-Life Assessment?
"Currently, there are 80 separate clinical trials evaluating Quality-of-Life Assessment. 4 of those active studies have reached Phase 3. Although the majority of research for Quality-of-Life Assessment is based in St Leonards, New South Wales, there are 2136 total locations running trials related to this topic."
How many study participants are there in total?
"In order for this clinical trial to move forward, 36 patients who match the pre-determined inclusion criteria must enroll. There are multiple hospitals and medical schools participating in this study, such as Rutgers New jersey Medical School located in Newark, New Jersey and Regions Hospital situated in Saint Paul, Minnesota."
Are there any slots left for volunteers in this experiment?
"The trial is searching for 36 patients at 72 locations."
Are research facilities in different states testing this new medication?
"Presently, this experiment is being conducted at 72 different research facilities. A few of the places where these sites are situated include Newark, Saint Paul and Jacksonville. If you are planning on enrolling in this trial, it would be advantageous to choose a location close to your home to limit travel time commitment."
The Quality-of-Life Assessment - is this something that the FDA has greenlit?
"Because there is only data supporting safety and no efficacy, our team has given Quality-of-Life Assessment a score of 2."
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