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Protein Kinase Inhibitor
Triple Drug Therapy for Melanoma
Phase 1
Waitlist Available
Led By Zeynep Eroglu, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have cytologically or histologically-confirmed unresectable melanoma that harbors a BRAF V600 mutation determined by pyrosequencing assay or equivalent genotyping assay in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory, meeting specific AJCC staging criteria.
Must have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat melanoma. The goal is to find the best dose of the new drugs while monitoring for side effects.
Who is the study for?
Adults with unresectable BRAF V600 mutated melanoma can join this trial. They must have a performance status indicating they are relatively active, agree to use contraception, and not be pregnant or nursing. Prior treatments for cancer are okay if side effects have settled, but no past use of BRAF, MEK or HSP90 inhibitors is allowed. Participants need functioning major organs and cannot have untreated brain metastases or certain serious health conditions.Check my eligibility
What is being tested?
The study aims to find the highest dose of XL888 that's safe when taken with vemurafenib and cobimetinib in patients with advanced melanoma. It will also assess how well participants tolerate this drug combination.See study design
What are the potential side effects?
Potential side effects include issues related to liver, kidney or bone marrow function; digestive problems; skin reactions from the drugs; fatigue; vision changes due to retinal complications; and possible heart problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma cannot be surgically removed and has a BRAF V600 mutation.
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I can take care of myself but might not be able to do heavy physical work.
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I have not taken BRAF, MEK, or HSP90 inhibitors for my condition.
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My liver, kidneys, and bone marrow are functioning well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment3 Interventions
Escalating Doses of XL888 with Vemurafenib plus Cobimetinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XL888
2017
Completed Phase 1
~70
Vemurafenib
2015
Completed Phase 3
~3100
Cobimetinib
2017
Completed Phase 3
~2660
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,466 Total Patients Enrolled
43 Trials studying Melanoma
3,192 Patients Enrolled for Melanoma
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,525 Total Patients Enrolled
5 Trials studying Melanoma
294 Patients Enrolled for Melanoma
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,663 Total Patients Enrolled
34 Trials studying Melanoma
1,661 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My melanoma cannot be surgically removed and has a BRAF V600 mutation.I have not consumed St. John's wort, hyperforin, or grapefruit juice in the last 7 days.You must have a tumor that can be measured using specific guidelines.I can take care of myself but might not be able to do heavy physical work.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am HIV-positive and on antiretroviral therapy.I have brain metastases, but they are stable or treated and not causing symptoms.I had cancer before, but it's under control and I'm not on cancer drugs now.I am not pregnant or cannot become pregnant.I will use birth control during and for 6 months after my treatment, as my doctor advises.I have not taken BRAF, MEK, or HSP90 inhibitors for my condition.I've had cancer treatment before, but any side effects are now mild.I do not have a condition that affects how my body absorbs medication.I have a history of serious heart problems.My liver, kidneys, and bone marrow are functioning well.I have been treated with BRAF, MEK, or HSP90 inhibitors.I am 18 years old or older.I have a history of eye conditions that could lead to serious retinal problems.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open enrollment opportunities for this research project?
"At this time, the trial is not accepting applicants. This research was first advertised on August 11th 2016 and its parameters were last edited on September 30th 2022. Those seeking alternative studies can look at 817 clinical trials for skin cancer or 74 for XL888 that are currently recruiting patients."
Answered by AI
Has the Food and Drug Administration accepted XL888 as a legitimate remedy?
"The limited data available in regards to XL888's safety and efficacy led our team at Power to assign it a score of 1 on the 1-3 scale."
Answered by AI
Have any other experiments previously been conducted using XL888?
"Currently, 74 studies are being conducted to explore the efficacy of XL888. Of those trials, 4 have reached Phase 3 and most sites for study participants are located in Taipei or New South Wales. However, there is a total number of 2116 locations with active clinical research involving this medication."
Answered by AI
What clinical conditions does XL888 target most frequently?
"Patients with metastatic melanoma, non-small cell lung carcinoma and unresectable melanoma may find relief from XL888 medication."
Answered by AI
What is the current size of the cohort enrolled in this research project?
"Unfortunately, this research is not currently recruiting participants. Initially posted on August 11th 2016 and recently updated September 30th 2022, it is inactive at the moment. However, 817 trials are presently looking for individuals with skin cancer and 74 studies require volunteers for XL888 treatments."
Answered by AI
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