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Kinase Inhibitor
E6201 + Dabrafenib for Brain Metastasis from Melanoma
Phase 1
Recruiting
Led By Hani M Babiker
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Seizures due to CNS metastases must be controlled with stable anti-epileptic treatment for >= 14 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of two drugs, E6201 and dabrafenib, for patients with melanoma that has spread to the brain.
Who is the study for?
Adults (18+) with stage IV BRAF V600-mutated melanoma that has spread to the brain. They must have at least one brain metastasis, be willing to use contraception, and have certain organ functions within normal limits. Prior immunotherapy is allowed if there's disease progression after treatment. Excluded are those with uncontrolled illnesses, recent heart issues, or who've had extensive prior treatments for metastatic disease.Check my eligibility
What is being tested?
The trial tests E6201 combined with dabrafenib on patients with melanoma in the brain due to a specific mutation (BRAF V600). It aims to find the safest dose and see how well these drugs work together compared to when they're used alone.See study design
What are the potential side effects?
Potential side effects include but are not limited to: fatigue, fever, skin rash, headache, joint pain, nausea. More serious risks may involve changes in liver function tests or development of new skin cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
Select...
My seizures caused by brain metastases have been under control for at least 14 days with stable medication.
Select...
My melanoma has a BRAF mutation, confirmed by a qualified lab test.
Select...
I have brain metastases, with or without symptoms.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I am 18 years old or older.
Select...
My melanoma is stage IV with a BRAF V600 mutation.
Select...
I can take pills and don't have major stomach or bowel issues affecting drug absorption.
Select...
I can swallow.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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
Secondary outcome measures
Incidence of adverse events
Overall extracranial response rate
Overall intracranial response rate
+2 moreOther outcome measures
BRAF mutational status
Side effects data
From 2016 Phase 3 trial • 251 Patients • NCT0122788940%
Arthralgia
38%
Hyperkeratosis
36%
Headache
33%
Pyrexia
29%
Nausea
29%
Alopecia
26%
Fatigue
26%
Skin papilloma
22%
Back pain
22%
Vomiting
20%
Asthenia
20%
Palmar-plantar erythrodysaesthesia syndrome
19%
Rash
19%
Nasopharyngitis
18%
Cough
17%
Diarrhoea
17%
Myalgia
17%
Pain in extremity
15%
Dry skin
14%
Constipation
14%
Decreased appetite
12%
Chills
12%
Seborrhoeic keratosis
12%
Dyspnoea
12%
Actinic keratosis
10%
Musculoskeletal pain
10%
Erythema
9%
Insomnia
9%
Palmoplantar keratoderma
8%
Abdominal pain
8%
Dizziness
8%
Papilloma
7%
Influenza like illness
7%
Weight decreased
7%
Hyperglycaemia
7%
Hair texture abnormal
7%
Skin lesion
6%
Pruritus
6%
Hypophosphataemia
6%
Abdominal pain upper
6%
Folliculitis
6%
Upper respiratory tract infection
6%
Alanine aminotransferase increased
6%
Paraesthesia
6%
Acrochordon
6%
Melanocytic naevus
5%
Hypertension
5%
Aspartate aminotransferase increased
5%
Musculoskeletal chest pain
5%
Anxiety
5%
Eczema
5%
Oropharyngeal pain
5%
Anaemia
4%
Squamous cell carcinoma
4%
Squamous cell carcinoma of skin
3%
Basal cell carcinoma
2%
Malignant melanoma
2%
Ejection fraction decreased
2%
Malignant melanoma in situ
2%
Atrial fibrillation
1%
Lip squamous cell carcinoma
1%
Blood creatine phosphokinase increased
1%
Focal nodular hyperplasia
1%
Breast cancer
1%
Pancreatitis acute
1%
Cellulitis
1%
Blood creatinine increased
1%
Ileus
1%
Anal abscess
1%
Erysipelas
1%
Papillary thyroid cancer
1%
Cataract
1%
Febrile neutropenia
1%
Lymphadenopathy
1%
Acute coronary syndrome
1%
Cardiac failure congestive
1%
Myocardial infarction
1%
Myocardial ischaemia
1%
Colitis
1%
Haemorrhoidal haemorrhage
1%
Large intestine perforation
1%
Pancreatic necrosis
1%
Small intestinal perforation
1%
Euthanasia
1%
Abdominal infection
1%
Localised infection
1%
Perineal abscess
1%
Pleural infection
1%
Pneumonia
1%
Head injury
1%
Radius fracture
1%
Blood bilirubin increased
1%
Dehydration
1%
Diabetes mellitus
1%
Diabetes mellitus inadequate control
1%
Hyperlipasaemia
1%
Hyponatraemia
1%
Osteoporotic fracture
1%
Parkinsonism
1%
Presyncope
1%
Syncope
1%
Psychotic disorder
1%
Renal failure
1%
Urinary bladder polyp
1%
Hypoxia
1%
Pleural effusion
1%
Pulmonary embolism
1%
Pulmonary oedema
1%
Respiratory distress
1%
Dermal cyst
1%
Hypotension
1%
Acute myocardial infarction
1%
Pancreatitis
1%
Gait disturbance
1%
Pleuritic pain
1%
Hepatitis E
1%
Hepatic pain
1%
Joint effusion
1%
Muscular weakness
1%
Acoustic neuroma
1%
Adenocarcinoma of the cervix
1%
Transient ischaemic attack
1%
Haematoma
1%
Haemorrhage
1%
Bowen's disease
1%
Soft tissue sarcoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
GSK2118436 150 mg BID
DTIC 1000 mg/m^2 in RP
GSK25118436 in the Crossover Phase
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (E6201, dabrafenib)Experimental Treatment5 Interventions
Patients receive MEK-1/MEKK-1 inhibitor E6201 IV over 2 hours on days 1, 4, 8, 11, 15, and 18, and dabrafenib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dabrafenib
2011
Completed Phase 3
~4120
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1730
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,122 Total Patients Enrolled
40 Trials studying Melanoma
2,505 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,664 Total Patients Enrolled
557 Trials studying Melanoma
193,215 Patients Enrolled for Melanoma
Hani M BabikerPrincipal InvestigatorMayo Clinic
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (E6201, dabrafenib)
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.
How many individuals are actively engaged in this clinical research?
"Affirmative. Clinicaltrials.gov confirms that this clinical experiment, which was first advertised on September 30th 2022, still needs to recruit patients. A total of 18 volunteers are required at one medical centre."
Answered by AI
Is this research effort currently enlisting participants?
"According to clinicaltrials.gov, this research is actively recruiting participants since the initial post on September 30th 2022. The trial specifications have been recently updated as of the same date."
Answered by AI
What implications does the MEK-1/MEKK-1 Inhibitor E6201 have on patient safety?
"The safety profile of MEK-1/MEKK-1 Inhibitor E6201 was estimated to be a 1 on the scale from 1 to 3, given that it is in Phase 1 trials and there are limited data points concerning its efficacy or potential risks."
Answered by AI
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