Viewing Study NCT04439305



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Last Modification Date: 2024-10-26 @ 1:38 PM
Study NCT ID: NCT04439305
Status: WITHDRAWN
Last Update Posted: 2020-07-20
First Post: 2020-06-18

Brief Title: Testing Dasatinib as a Potential Targeted Treatment in Cancers With DDR2 Genetic Changes MATCH-Subprotocol X
Sponsor: National Cancer Institute NCI
Organization: National Cancer Institute NCI

Study Overview

Official Title: MATCH Treatment Subprotocol X Phase II Study of Dasatinib in Patients With Tumors With DDR2 Mutations
Status: WITHDRAWN
Status Verified Date: 2020-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: zero accrual
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 identifies the effects of dasatinib in patients whose cancer has a genetic change called DDR2 mutation Dasatinib may block proteins called tyrosine kinases which may be needed for cancer cell growth Researchers hope to learn if dasatinib will shrink this type of cancer or stop its growth
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 dasatinib orally PO once daily QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity

After completion of study treatment patients are followed up every 3 months if less than 2 years from study entry and then every 6 months for year 3 from study entry

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
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
NCI-2020-03342 REGISTRY None None
EAY131-X OTHER None None
EAY131-X OTHER None None
U10CA180820 NIH None None
U24CA196172 NIH CTEP httpsreporternihgovquickSearchU24CA196172