Clinical Trial: NCT01541709 - My Cancer Genome

NCT01541709

Description:

KIT exon 9 mutants had poorer survival compared with KIT exon 11 mutants when they were treated with the same dose of imatinib, 400 mg per day, and that patients with KIT exon 9 mutation had better progression-free survival with imatinib treatment at an escalated dose, 800 mg per day, than with imatinib treatment at a dose of 400 mg per day.10,11 Based on the results, imatinib 800 mg per day is now considered the standard dose for the treatment of patients with metastatic or unresectable GIST showing KIT exon 9 mutation in Western countries.

Related Conditions:

Gastrointestinal Stromal Tumor

Recruiting Status:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT01541709

Trial Eligibility

Document

Title

Brief Title: Imatinib Dose Escalation to 800 mg/Day in Korean Patients With Metastatic or Unresectable GIST Harboring KIT Exon 9 Mutation: KENEDI
Official Title: 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: Imatinib Dose Escalation

Clinical Trial IDs

ORG STUDY ID: AMC1102
NCT ID: NCT01541709

Conditions

Gastrointestinal Stromal Tumors

Interventions

Drug	Synonyms	Arms
imatinib		Imatinib

Purpose

Detailed Description

      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.

Trial Arms

Name	Type	Description	Interventions
Imatinib	Experimental		imatinib

Eligibility Criteria

        Inclusion Criteria:

          -  Age 18 or older

          -  Histologically confirmed metastatic or unresectable GIST with CD117(+), DOG-1 (+), or
             KIT mutation

          -  ECOG PS(Eastern Cooperative Oncology Group Performance Status) 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(radiofrequency ablation), 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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	progression-free survival (PFS)
Time Frame:	up to 24months
Safety Issue:
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(Response Evaluation Criteria in Solid Tumors) version 1.0

Secondary Outcome Measures

Measure:	disease control rate
Time Frame:	Up to 24weeks
Safety Issue:
Description:

Measure:	safety control rate
Time Frame:	up to 24months
Safety Issue:
Description:

Measure:	overall survival (OS)
Time Frame:	up to 24months
Safety Issue:
Description:

Measure:	imatinib PK(pharmacokinetics) (Cmin)
Time Frame:	up to 24months
Safety Issue:
Description:

Measure:	percentage of successful dose escalation
Time Frame:	up to 24months
Safety Issue:
Description:

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	Asan Medical Center

Trial Keywords

This is a single-center
prospective
single-arm
open-label phase II study

Last Updated

June 24, 2021

Clinical Trials /

Imatinib Dose Escalation to 800 mg/Day in Korean Patients With Metastatic or Unresectable GIST Harboring KIT Exon 9 Mutation: KENEDI