A phase II study of imatinib dose escalation to 800 mg/day in Asian patients with metastatic or unresectable GIST harboring KIT exon 9 mutation

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0008415

Enrollment

Registered

2023-05-11

Start date

2012-11-21

Completion date

Unknown

Last updated

2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Drug :Imatinib(Glivec) Dose, prescription, treatment cycle: 400mg/day imatinib for 4-6 weeks, if tolerability of imatinib 600mg/day for another 4 weeks, 800mg until disease progression, unaccep

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 or older 2. Histologically confirmed metastatic or unresectable GIST with CD117(+), DOG-1 (+), or KIT mutation 3. ECOG PS 0~2 4. Primary mutation at KIT exon 9 5. Imatinib treatment for less than 4 weeks from the first dose at 400 mg per day 6. No prior use of tyrosine kinase inhibitors (but, patients who have recurrence 6 months after completion of adjuvant imatinib at a dose of 400 mg per day can be enrolled in this study) 7. At least one evaluable disease by RECIST v1.0 8.Resolution of all toxic effects of prior treatments (chemotherapy, surgery, RFA, radiotherapy, and/or TACE) 9. Adequate bone marrow function as defined by platelets = 75 x 109/L and neutrophils = 1.5 x 109/L within 1 week prior to the first dose of imatinib at 400 mg per day 10. Adequate renal function, with serum creatinine 5 years previously without evidence of relapse 13. Provision of a signed written informed consent

Exclusion criteria

Exclusion criteria: 1. Severe co-morbid illness and/or active infections 2. Pregnant or lactating women 3. History of other malignancies except basal cell carcinoma and carcinoma in situ of uterine cervix 4. CNS metastasis 5. Clinically significant bleeding in GI tract 6. GI obstruction or malabsorption 7. Known hypersensitivity to imatinib

Design outcomes

Primary

Measure	Time frame
2-year progression-free survival	—

Secondary

Measure	Time frame
Safety	—

Countries

Korea, Republic of

Contacts

Public ContactMin-Hee Ryu

Asan Medical Center

miniryu@amc.seoul.kr+82-2-3010-2043

Outcome results