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

NCT01541709 | Unknown Phase 2

• 1 other identifier: AMC1102
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Stromal Tumors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  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

  up to 24months

Secondary Outcomes (5)

• disease control rate

  Up to 24weeks

• safety control rate

  up to 24months

• overall survival (OS)

  up to 24months

• imatinib PK(pharmacokinetics) (Cmin)

  up to 24months

• percentage of successful dose escalation

  up to 24months

Study Arms (1)

Imatinib

EXPERIMENTAL

Drug: imatinib

Interventions

imatinib DRUG

The patients will receive 400 mg per day of imatinib for 4 weeks, and then 600mg per day (300 mg po bid) for 4 weeks if tolerable to 400 mg per day, and then 800 mg per day (400 mg po bid)

Imatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Min-Hee Ryu, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 1, 2012
• Study Start: March 1, 2012
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

KR (1)