Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303167
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-03-08
Brief Title:
Testing AZD9291 as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes MATCH-Subprotocol E
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
MATCH Treatment Subprotocol E Osimertinib AZD9291 in Patients With Tumors Having EGFR T790M Mutations or Rare Activating Mutations of EGFR
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 evaluates the effectiveness of osimertinib AZD9291 in treating patients with cancer that has certain genetic changes called EGFR mutations Osimertinib is in a class of medications called kinase inhibitors It works by blocking the action of mutant forms of the EGFR protein which play a key role in tumor cell growth Osimertinib may cause tumor cell death and inhibit tumor growth in EGFR-overexpressing tumor cells thereby stopping or slowing the spread of tumor 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 osimertinib AZD9291 orally PO once daily QD 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 throughout the trial echocardiography ECHO or multigated acquisition scan MUGA during screening and biopsy and collection of blood samples on trial and 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 year
THE MATCH SCREENING TRIAL
Please see NCT02465060 for information on the MATCH Screening Protocol and applicable documents
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 osimertinib AZD9291 orally PO once daily QD 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 throughout the trial echocardiography ECHO or multigated acquisition scan MUGA during screening and biopsy and collection of blood samples on trial and 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 year
THE MATCH SCREENING TRIAL
Please see NCT02465060 for information on the MATCH Screening Protocol and applicable documents
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-2024-01150 | REGISTRY | None | None |
| EAY131-E | OTHER | None | None |
| EAY131-E | OTHER | None | None |
| U10CA180820 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180820 |