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A Phase II Study of Imatinib Dose Escalation to 800 mg/Day in Korean Patients With Metastatic or Unresectable GIST Harboring KIT Exon 9 Mutation


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Stromal Tumors

Thank you

Trial Information

A Phase II Study of Imatinib Dose Escalation to 800 mg/Day in Korean Patients With Metastatic or Unresectable GIST Harboring KIT Exon 9 Mutation


According to our previous prospective phase II study of imatinib 400 mg per day in
metastatic or unresectable GIST, hematologic and non-hematologic toxicities were more
frequent in Korean patients compared to the Western studies.7 It may be caused by relatively
higher exposure to imatinib per body surface area in Korean patients than in Western
population because the weight and height of Korean patients are relatively smaller than
Western people. So, we plan to start imatinib at 400 mg per day and then sequentially
escalate the doses of imatinib in this study.


Inclusion Criteria:



- Age 18 or older

- Histologically confirmed metastatic or unresectable GIST with CD117(+), DOG-1 (+), or
KIT mutation

- ECOG PS 0~2

- Primary mutation at KIT exon 9

- Imatinib treatment for less than 4 weeks from the first dose at 400 mg per day

- 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)

- At least one evaluable disease by RECIST v1.0

- Resolution of all toxic effects of prior treatments (chemotherapy, surgery, RFA,
radiotherapy, and/or TACE)

- 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)

- Adequate renal function, with serum creatinine < 1.5 x ULN (within 1 week prior to
the first dose of imatinib at 400 mg per day)

- Adequate hepatic function with serum total bilirubin < 1.5 x ULN, alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN in the absence
of liver metastases, or < 5 x UNL in the presence of liver metastases (within 1 week
prior to the first dose of imatinib at 400 mg per day)

- No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ
of the uterine cervix or any other cancer except where treated with curative intent >
5 years previously without evidence of relapse

- Provision of a signed written informed consent

Exclusion Criteria:

- Severe co-morbid illness and/or active infections

- Pregnant or lactating women

- History of other malignancies except basal cell carcinoma and carcinoma in situ of
uterine cervix

- CNS metastasis

- Clinically significant bleeding in GI tract

- GI obstruction or malabsorption

- Known hypersensitivity to imatinib

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival (PFS)

Outcome Description:

evaluated with Triphasic or dynamic CT scans of abdomen & pelvis, and other involved sites. Follow-up CT scans will be performed at 4 weeks and 12 weeks after the first dose of imatinib at 400 mg per day, and then every 3 months until disease using RECIST version 1.0

Outcome Time Frame:

up to 24months

Safety Issue:

No

Principal Investigator

Yoon-Koo Kang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

AMC1104

NCT ID:

NCT01541709

Start Date:

March 2012

Completion Date:

August 2016

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • This is a single-center
  • prospective
  • single-arm
  • open-label phase II study
  • Gastrointestinal Stromal Tumors

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