A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor

STATUS

Recruiting
participants needed

87
sponsor

CStone Pharmaceuticals

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Updated on 19 February 2024

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measurable disease

imatinib

tyrosine

kinase inhibitor

gastrointestinal stromal tumor

stromal tumor

pdgfra gene

blu-285

adjuvant

Summary

This study is an open-label, multicenter, phase I/II study to evaluate the safety, PK and clinical efficacy of avapritinib in Chinese subjects with unresectable or metastatic GIST. The study consists of two parts: dose escalation (phase I) and dose expansion (phase II).

Details

Condition	gastrointestinal stromal tumor
Age	18years - 100years
Treatment	CS3007 (BLU-285)
Clinical Study Identifier	NCT04254939
Sponsor	CStone Pharmaceuticals
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	For phase I study, the subject must have histologically or cytologically confirmed unresectable or metastatic GIST that progressed after imatinib and at least one additional TKI treatment, or who cannot tolerate the standard treatment or have D842V mutation in the PDGFR gene
	For phase II study
	Group 1: Chinese subjects with unresectable GIST harboring D842V mutation in PDGFR gene
	ii) Group 2: Chinese subjects with unresectable GIST that has progressed
	following imatinib treatment or who don't tolerate imatinib (including in the
	adjuvant setting) and who have not received any other kinase inhibitor
	treatment. Patients must not have a known D842V mutation in PDGFR gene
	iii) Group 3: Chinese subjects with unresectable GIST that doesn't harbor
	D824V mutation in PDGFR gene and that has progressed despite treatment with
	imatinib and at least another tyrosine kinase inhibitor
	\. Subjects with at least one measurable lesion as defined per RECIST v1.1
	\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
Exclusion Criteria
	Subject has any of the laboratory results that meet exclusion criteria
	Subjects who have previously received antineoplastic medication, including Chinese herbal drugs or Chinese medicine products with antineoplastic indications, for less than 5 half-lives or 14 days, whichever is shorter, prior to the first dose of the investigational product
	The subject received neutrophil growth factor support within 14 days prior to the first dose of investigational product
	Subjects received treatment with a strong inhibitor or strong or moderate inducer of cytochrome P450 (CYP) 3A4 within 14 days prior to the first dose of study drug, or requires continuous intake of above medications or foods during study period
	Subject received a major surgery (not including minor procedures, e.g., central venous catheterization, tumor needle biopsy, feeding tube placement) within 14 days prior to the first dose of investigational product
	Diagnosis of any other malignancy within 1 year prior to the first dose of investigational product or the subject is under treatment for another malignancy
	Corrected QT interval > 450 msec calculated using Fridericia's formula
	Subject has history of seizure (e.g. epilepsy) or requires antiepileptic medication treatment
	History of cerebrovascular accident or transient ischemic attack within one year prior to the first dose of the investigational product
	Known risk of intracranial hemorrhage, e.g., history of cerebral aneurysm or subdural or subarachnoid hemorrhage
	With primary brain malignancy or brain metastasis
	With clinically significant, uncontrolled cardiovascular disease, including congestive heart failure of New York Heart Association (NYHA) class II, III or IV, myocardial infarction or unstable angina in the past 6 months, or uncontrolled hypertension
	Unwilling or unable to comply with scheduled visits, treatment plan, laboratory tests or other study procedures/restrictions
	With previous or current clinically significant disorder, medical condition, history of surgery, physical issue or laboratory finding, which, in the investigator's judgment, might affect the subject's safety, change the absorption, distribution, metabolism or excretion of the investigational product, or interfere with the evaluation of study result

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A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor