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Tyrosine Kinase Inhibitor

Subprotocol C1 (MET amplification) for Solid Tumors

Phase 2
Waitlist Available
Led By David S Hong
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a drug called crizotinib in patients with advanced or refractory solid tumors, lymphoma, or multiple myeloma that have a specific gene amplification. Criz

Who is the study for?
This trial is for patients with advanced or treatment-resistant solid tumors, lymphoma, or multiple myeloma that have MET gene amplification. Participants should be those whose cancer has spread and who haven't responded to standard treatments.Check my eligibility
What is being tested?
The effectiveness of Crizotinib, a tyrosine kinase inhibitor medication, is being tested on participants. The study involves taking the drug and undergoing radiologic exams, biopsies, and biospecimen collection to see how well it works against these cancers.See study design
What are the potential side effects?
Crizotinib may cause side effects such as vision problems, nausea, diarrhea, liver problems (elevated liver enzymes), heart issues (QT prolongation), lung inflammation (pneumonitis), and others.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years 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
Overall survival (OS)
Progression free survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subprotocol C1 (MET amplification)Experimental Treatment4 Interventions
Patients receive crizotinib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation and collection of blood samples throughout the study. Patients may undergo biopsy at screening, on study, and/or at end of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crizotinib
2014
Completed Phase 3
~2370
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,675 Previous Clinical Trials
40,926,927 Total Patients Enrolled
David S HongPrincipal InvestigatorECOG-ACRIN Cancer Research Group
6 Previous Clinical Trials
230 Total Patients Enrolled

Frequently Asked Questions

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

Has the use of Subprotocol C1 (MET amplification) been given official clearance by the FDA?

"The safety evaluation for Subprotocol C1 (involving MET amplification) is rated at 2 by our team, reflecting the fact that this Phase 2 trial has some evidence supporting safety but lacks data on efficacy."

Answered by AI

Are patients currently able to participate in this ongoing research study?

"Information available on clinicaltrials.gov indicates that patient recruitment is not ongoing for this particular trial. The initial posting date was the 30th of May, 2016, with the most recent update occurring on April 9th, 2024. Although enrollment is currently closed, it's worth noting that there are a substantial number of other trials - precisely 4871 - actively seeking participants during this period."

Answered by AI
~3 spots leftby Nov 2024