Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360575
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-10
Brief Title:
Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes MATCH - Subprotocol C2
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
MATCH Treatment Subprotocol C2 Crizotinib in Patients With Tumors With MET Exon 14 Deletion
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 to treat patients with cancers with MET exon 14 deletion genetic changes Crizotinib is in a group of medications called tyrosine kinase inhibitors It works by blocking 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 undergo tumor biopsy on study and undergo radiologic evaluation and blood sample collection throughout the study
After completion of study treatment patients followed up every 3 months for 2 years then every 6 months for year 3
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 undergo tumor biopsy on study and undergo radiologic evaluation and blood sample collection throughout the study
After completion of study treatment patients followed up every 3 months for 2 years then every 6 months for year 3
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA180820 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180820 |
| NCI-2024-01127 | REGISTRY | None | None |
| EAY131-C2 | OTHER | None | None |
| EAY131-C2 | OTHER | None | None |