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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

Must not have

Patients with any prior ALK inhibition

Patients with prior RT or clinically relevant major surgery (e.g. craniotomy, metastasectomy) within 2 weeks prior to first day of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously received ALK inhibitors for treatment.

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I haven't had major surgery or radiation therapy in the last 2 weeks.

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I have taken strong medications that affect liver enzymes recently.

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I have only received hormonal therapy for my hormone-sensitive cancer.

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I do not have serious heart issues or active infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

clinical benefit rate (CBR)

Side effects data

From 2017 Phase 1 & 2 trial • 2 Patients • NCT02898116

100%

Hypoalbuminaemia

50%

Fatigue

50%

Blood alkaline phosphatase increased

50%

Lymphocyte count decreased

50%

Anaemia

50%

Pulmonary oedema

50%

Eosinophilia

50%

Arthralgia

50%

Dysgeusia

50%

Weight decreased

50%

Hyponatraemia

50%

Hypocalcaemia

50%

Insomnia

50%

Nausea

50%

Decreased appetite

50%

Hypersensitivity

50%

Dyspnoea

50%

Cough

50%

Musculoskeletal pain

50%

Pyrexia

50%

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Ensartinib (200 mg)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 11Eligibility criteria met