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Tyrosine Kinase Inhibitor
Ensartinib for Melanoma
Phase 2
Waitlist Available
Led By Alexander Shoushtari
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have acceptable liver, renal, and hematological function: total bilirubin ≤1.5x upper limit of normal (ULN); patients with Gilbert's Syndrome must have bilirubin ≤3x ULN, Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤3 x ULN (≤5x if liver metastases are present), Estimated glomerular filtration rate (GFR) ≥ 30 mL/min, Hemoglobin ≥9 g/dL, Neutrophils ≥1.5 x 10^9/L, Platelets ≥100 x 10^9/L, Prothrombin time, international normalized ratio [INR], and/or activated partial thromboplastin time within ≤1.5 x ULN
Tumors must harbor an alteration in ALK using a CLIA-certified laboratory, including, but not limited to, ALKATI, ALK fusions, or ALK mutations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
Study Summary
This trial is testing a new melanoma drug to see if it's effective and has minimal side effects.
Who is the study for?
This trial is for adults with advanced malignant melanoma that has a specific ALK alteration. Participants must have tried PD-1 based therapy (and BRAF inhibitors if applicable) without success, and should not be pregnant or breastfeeding. They need to have good liver, kidney, and blood function and can't have used certain other cancer treatments or strong CYP3A affecting drugs recently.Check my eligibility
What is being tested?
The trial is testing ensartinib's effectiveness on melanoma with ALK alterations. Ensartinib is an investigational drug targeting this abnormality in the hope of treating the cancer more effectively.See study design
What are the potential side effects?
While specific side effects for ensartinib are not listed here, similar medications often cause issues like nausea, fatigue, skin reactions, vision changes, and potential heart problems among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver, kidney, and blood tests are within the required ranges.
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My tumor has an ALK alteration.
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My cancer can be measured by scans and has not been treated locally in the last 30 days or has grown despite treatment.
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I have been diagnosed with advanced melanoma.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
clinical benefit rate (CBR)
Side effects data
From 2017 Phase 1 & 2 trial • 2 Patients • NCT02898116100%
Hypoalbuminaemia
50%
Eosinophilia
50%
Pulmonary oedema
50%
Dysgeusia
50%
Decreased appetite
50%
Hyponatraemia
50%
Nausea
50%
Arthralgia
50%
Blood alkaline phosphatase increased
50%
Insomnia
50%
Fatigue
50%
Lymphocyte count decreased
50%
Anaemia
50%
Hypocalcaemia
50%
Weight decreased
50%
Hypersensitivity
50%
Dyspnoea
50%
Cough
50%
Musculoskeletal pain
50%
Pyrexia
50%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ensartinib (200 mg)
Trial Design
1Treatment groups
Experimental Treatment
Group I: ensartinibExperimental Treatment2 Interventions
The screening portion of the trial will test archival tumor material for the presence of ALKATI using a Nanostring-based RNA assay for any patients deemed to be current or future candidates for this trial. This will require approximately 5 formalin-fixed paraffin- embedded (FFPE) slides of 5-8 micron thickness. For the treatment portion of the study, all patients will receive ensartinib orally at a dose of 225mg daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ensartinib
2017
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
Xcovery Holdings, Inc.Industry Sponsor
9 Previous Clinical Trials
600 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,604 Total Patients Enrolled
76 Trials studying Melanoma
15,960 Patients Enrolled for Melanoma
Xcovery Holding Company, LLCIndustry Sponsor
8 Previous Clinical Trials
512 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously received ALK inhibitors for treatment.I had lung inflammation before, but it's resolved now.I haven't had any cancer treatments in the last 3 weeks or within the last treatment cycle, whichever is shorter.My blood pressure is not well-controlled according to my doctor.I haven't had major surgery or radiation therapy in the last 2 weeks.I have taken strong medications that affect liver enzymes recently.My cancer progressed after PD-1 therapy, and if it's BRAF V600 positive, I've had BRAF inhibitors.I haven't taken BRAF/MEK inhibitors in the last 3 weeks.My liver, kidney, and blood tests are within the required ranges.I have only received hormonal therapy for my hormone-sensitive cancer.I do not have serious heart issues or active infections.I haven't taken immune-boosting cancer drugs like ipilimumab, pembrolizumab, or nivolumab recently.I may have heart issues but can possibly join after talking to the study leader.My tumor has an ALK alteration.My cancer can be measured by scans and has not been treated locally in the last 30 days or has grown despite treatment.I have brain metastases but no symptoms, or they've been treated and are stable without increased steroids.I do not have any active cancer that could affect my participation in the study, except for melanoma.I have been diagnosed with advanced melanoma.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: ensartinib
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 venues are currently administering this clinical experiment?
"This clinical trial is actively recruiting patients across 4 locations; Memorial Sloan Kettering Westchester in Harrison, Memoral Sloan Kettering Monmouth in Middletown, and two other sites located in Montvale."
Answered by AI
Has Ensartinib met the requirements for federal authorization?
"Despite no efficacy data existing, the safety of ensartinib was estimated to be a 2 on our scale due to Phase 2 trial results."
Answered by AI
Is this a pioneering clinical trial?
"Since its inception in 2016, sponsored by Xcovery Holding Company, LLC., Ensartinib has been tested extensively. Following the initial 290-patient study of Phase 3 drugs, it was approved and is currently being trialled across 22 countries with 449 sites involved."
Answered by AI
Are there other investigations into the efficacy of Ensartinib?
"At present, there is one Phase 3 clinical trial into Ensartinib and seven active studies. Although most of these are in New york City, ensartinib-related trials can be found at 796 sites across the USA."
Answered by AI
How many participants can be recruited for the trial?
"This clinical trial has ceased recruitment of participants. First posted on 10th January 2018 and last updated 25th January 2022, applicants are instead directed to the 754 trials actively enrolling patients with melanoma or one of seven studies that require Enartinib volunteers."
Answered by AI
Does this clinical experiment still have room for new participants?
"Unfortunately, this clinical trial has suspended its recruitment of patients. Initially posted on October 1st 2018 and last edited on January 25th 2022, those searching for alternate trials can find 754 studies recruiting melanoma patients or seven investigations admitting participants to Ensartinib research."
Answered by AI
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