Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357975
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-09
Brief Title:
Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Genetic Changes MATCH - Subprotocol C1
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
MATCH Treatment Subprotocol C1 Crizotinib in Patients With Tumors With MET Amplification
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II MATCH treatment trial tests how well crizotinib works in treating patients with solid tumors lymphoma or multiple myeloma that may have spread from where it first started to nearby tissue lymph nodes or distant parts of the body advanced or that does not respond to treatment refractory and who have MET gene amplification Crizotinib is in a class of medications called tyrosine kinase inhibitors It works by blocking the action of enzymes that cancer cells need to grow and spread It may also prevent the growth of new blood vessels that tumors need to grow
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the proportion of patients with objective response OR to targeted study agents in patients with advanced refractory cancerslymphomasmultiple myeloma
SECONDARY OBJECTIVES
I To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancerslymphomasmultiple myeloma
II To evaluate time until death or disease progression III To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic ribonucleic acid RNA protein and imaging-based assessment platforms
IV To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens
OUTLINE
Patients receive crizotinib orally PO twice daily 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 andor at end of treatment
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 1 additional year
I To evaluate the proportion of patients with objective response OR to targeted study agents in patients with advanced refractory cancerslymphomasmultiple myeloma
SECONDARY OBJECTIVES
I To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancerslymphomasmultiple myeloma
II To evaluate time until death or disease progression III To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic ribonucleic acid RNA protein and imaging-based assessment platforms
IV To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens
OUTLINE
Patients receive crizotinib orally PO twice daily 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 andor at end of treatment
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 1 additional year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01126 | REGISTRY | None | None |
| EAY131-C1 | OTHER | None | None |
| EAY131-C1 | OTHER | None | None |
| U10CA180820 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180820 |