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Tyrosine Kinase Inhibitor

Crizotinib for Cancer with ALK Genetic Changes

Phase 2

Waitlist Available

Led By Alice T Shaw

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)

Patients must have an ALK rearrangement as defined via the MATCH Master Protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Awards & highlights

Study Summary

This trial is testing crizotinib to see if it can shrink or stop the growth of cancer in patients with a genetic change called ALK rearrangement.

Who is the study for?

This trial is for patients with various cancers that have a specific genetic change called ALK rearrangement. They must not have non-small cell lung cancer or certain lymphomas, no history of interstitial lung disease, and cannot be allergic to crizotinib. Prior treatments with ALK inhibitors disqualify them, as do untreated brain metastases or those on certain drugs affecting liver enzymes.Check my eligibility

What is being tested?

The trial tests Crizotinib's effectiveness in shrinking or stopping the growth of cancers with the ALK genetic change. It's a phase II study where all participants receive Crizotinib to see how well it works against these types of cancer cells.See study design

What are the potential side effects?

Crizotinib may cause side effects like vision problems, nausea, diarrhea, constipation, vomiting, swelling in hands/feet/ankles/lower legs (edema), dizziness and tiredness. Liver issues can also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My recent ECG showed no significant heart issues.

Select...

My cancer has an ALK gene change.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

6-month Progression-free Survival (PFS) Rate

Progression Free Survival (PFS)

Side effects data

From 2020 Phase 3 trial • 207 Patients • NCT01639001

55%

White blood cell count decreased

50%

Nausea

49%

Anaemia

46%

Vomiting

45%

Alanine aminotransferase increased

37%

Neutropenia

35%

Aspartate aminotransferase increased

33%

Neutrophil count decreased

33%

Decreased appetite

27%

Constipation

27%

Platelet count decreased

24%

Cough

21%

Haemoglobin decreased

20%

Leukopenia

17%

Chest pain

17%

Fatigue

16%

Blood albumin decreased

16%

Hyponatraemia

15%

Pyrexia

13%

Back pain

11%

Dizziness

11%

Dyspnoea

11%

Alopecia

10%

Thrombocytopenia

10%

Asthenia

Diarrhoea

Headache

Insomnia

Red blood cell count decreased

Phlebitis

Visual impairment

Upper respiratory tract infection

Nasopharyngitis

Hypoalbuminaemia

Haemoptysis

Pruritus

Rash

Hypokalaemia

Lymphocyte count decreased

Blood bilirubin increased

Pain in extremity

Abdominal distension

Pain

Productive cough

Oedema peripheral

Musculoskeletal pain

Arthralgia

Vision blurred

Chest discomfort

Blood alkaline phosphatase increased

Gamma-glutamyltransferase increased

Paraesthesia

Hypocalcaemia

Abdominal pain

Protein total decreased

Abdominal pain upper

Hypoaesthesia

Pleural effusion

Disease progression

Death

Blood creatinine increased

Pneumonia

Oedema

Blood lactate dehydrogenase increased

Hypoproteinaemia

Hypertension

Pericardial effusion

Syncope

Transaminases increased

Cerebral infarction

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy

Crizotinib

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (crizotinib)Experimental Treatment1 Intervention

Patients receive crizotinib 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

Crizotinib

2014

Completed Phase 3

~2370

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,366 Total Patients Enrolled

Alice T ShawPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Crizotinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04439266 — Phase 2

Cancer Research Study Groups: Treatment (crizotinib)

Cancer Clinical Trial 2023: Crizotinib Highlights & Side Effects. Trial Name: NCT04439266 — Phase 2

Crizotinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439266 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what medical scenarios is Crizotinib typically prescribed?

"Crizotinib is typically prescribed for amino acid supplementation. Additionally, it has been used to treat renal dysfunction and kidney failure."

Answered by AI

Are there any vacancies for this clinical trial?

"As of this moment, no more patients are being recruited for this clinical trial. It first appeared on August 12th 2015 and was last updated 8/25/2022. If you're still seeking out other studies, there are presently 4670 trials recruiting participants with refractory lymphomas as well as 70 studies enrolling Crizotinib candidates."

Answered by AI

What are the definitive aims of this trial?

"The primary aim of this medical trial, which will be tracked for up to 3 years post registration and assessed at baseline then every 2 cycles or every 3 cycles, is the Objective Response Rate. Secondary outcomes are Progression Free Survival (PFS) - time from treatment start date till progression or death due to any cause- Median PFS using Kaplan-Meier method; Overall survival (OS)-time from treatment start date until death caused by any reason with censoring of living patients at last contact date evaluated specifically for each drug; and Progression free survival (PFS) - same as defined above but estimated through the use of Kaplan-"

Answered by AI

Has Crizotinib been granted permission for use by the US Food and Drug Administration?

"The safety of Crizotinib is rated 2 on a scale of 1-3, as this Phase 2 trial has only provided some evidence for the drug's security but not its efficacy."

Answered by AI

Is this an unprecedented clinical trial?

"Since its inception in 2007, sponsored by Baxter Healthcare Corporation, Crizotinib has undergone a series of clinical trials culminating with Phase 4 approval. Currently, there are 70 live studies for this drug across 1216 cities and 37 countries."

Answered by AI

What is the upper limit for participants in this medical investigation?

"Currently, this experiment is not open to new patients. Although the clinical trial was posted on August 12th, 2015 and last updated on August 25th 2022, there are 4 670 trials currently recruiting individuals with refractory lymphomas and 70 studies involving Crizotinib that have vacancies."

Answered by AI

Recent research and studies

npj Precision OncologyJournal

Crizotinib in Patients with Tumors Harboring ALK or ROS1 Rearrangements in the NCI-MATCH Trial

Mansfield, A. S., Z. Wei, R. Mehra, A. T. Shaw, C. H. Lieu, P. M. Forde, A. E. Drilon, et al.. 2022. “Crizotinib in Patients with Tumors Harboring ALK or ROS1 Rearrangements in the NCI-MATCH Trial”. Npj Precision Oncology. Springer Science and Business Media LLC. doi:10.1038/s41698-022-00256-w.

clinicaltrials.govStudy

Testing Crizotinib as a Potential Targeted Treatment in Cancers With ALK Genetic Changes (MATCH-Subprotocol F)

2015. "Testing Crizotinib as a Potential Targeted Treatment in Cancers With ALK Genetic Changes (MATCH-Subprotocol F)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04439266.