Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390852
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-27
Brief Title:
Testing LOXO-101 as Potentially Targeted Treatment in Cancers With NTRK Genetic Changes MATCH - Subprotocol Z1E
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
MATCH Treatment Subprotocol Z1E Larotrectinib LOXO-101 in Patients With Tumors With NTRK Fusions
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 larotrectinib LOXO-101 works in treating patients with cancer that has certain genetic changes Larotrectinib LOXO-101 is used in patients whose cancer has a mutated changed form of a gene called NTRK It is in a class of medications called kinase inhibitors It works by blocking the action of an abnormal protein that signals cancer cells to multiply This helps slow or stop the spread of cancer cells
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 larotrectinib LOXO-101 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 Additionally patients undergo computed tomography CT or magnetic resonance imaging MRI during screening and on study as well as during follow-up as clinically necessary Patients also undergo biopsies and blood sample collection on study
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 1 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 larotrectinib LOXO-101 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 Additionally patients undergo computed tomography CT or magnetic resonance imaging MRI during screening and on study as well as during follow-up as clinically necessary Patients also undergo biopsies and blood sample collection on study
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 1 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-2024-01138 | REGISTRY | None | None |
| EAY131-Z1E | OTHER | None | None |
| EAY131-Z1E | OTHER | None | None |
| U10CA180820 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180820 |