A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor (NCT04254939) | Clinical Trial Compass
CompletedPhase 1/2
A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor
China65 participantsStarted 2019-08-15
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 PDGFRα gene.
✓. For phase II study:
✓. Subjects with at least one measurable lesion as defined per mRECIST v1.1
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
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.
✕
What they're measuring
1
Phase I: Recommended Phase II dose (RP2D), incidence of dose limiting toxicities (DLT) in Cycle 1, incidence and severity of adverse events and serious adverse events and changes in vital signs, clinical laboratory results and ECG findings
Timeframe: at the end of Cycle 1 (each cycle is 28 days) for RP2D and DLT; during every cycle through 30 days after the last dose of study drug, an average of approximately 24 months, for other measures
2
Phase II: ORR based on mRESIST 1.1
Timeframe: At Cycle 3 (each cycle is 28 days) Day 1, then every 2 cycles until Cycle 13, they every 3 cycles through study completion, disease progression or patient discontinuation from the study (whichever comes first), an average of approximately 24 months
. 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.