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Rechallenge of Imatinib in GIST Having no Effective Treatment

Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastrointestinal Stromal Tumors

Intervention: Imatinib (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Asan Medical Center

Official(s) and/or principal investigator(s):
Yoon-Koo Kang, MD, PhD, Principal Investigator, Affiliation: Asan Medical Center


The objective of this study is to compare the clinical outcomes following resumption of dosing (re-challenge) with Imatinib plus best supportive care versus placebo plus best supportive care in patients with advanced/incurable Gastrointestinal Stromal Tumors following failure of prior imatinib and sunitinib therapies.

Clinical Details

Official title: A Prospective, Double Blind, Randomized, Placebo-Controlled Phase III Trial of Imatinib Re-Challenge in Patients With Gastrointestinal Stromal Tumor Who Had Benefit From Prior Imatinib But Progression From Both Imatinib and Sunitinib

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Progression-free Survival

Secondary outcome:

Disease Control Rate

Progression Free Survival

Response Rate

Overall Survival(OS) and Time to Progression(TTP)

Safety and Tolerability of Imatinib


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patients aged 18 years and older

- Patients with metastatic or unresectable malignant gastrointestinal stromal tumour

which has been histologically confirmed by the detection of CD117 on immunohistochemical staining or genetically confirmed by the detection of mutation in KIT or PDGFRα genes on direct sequencing of tumor DNA.

- Prior benefit from 1st line imatinib defined as complete response, partial response,

or stable disease at 6 months after the start of 1st line imatinib

- Patients whose disease has progressed despite at least both prior imatinib therapy

(400mg/day) and then subsequently also failure of prior sunitinib therapy.

- ECOG(Eastern Cooperative Oncology Group) performance status 0 ~ 3

- Adequate bone marrow function as defined by platelets ≥ 75 x 109/L and neutrophils ≥

1. 5 x 109/L

- Adequate renal function, with serum creatinine < 1. 5 x upper limit of normal

- Adequate hepatic function with serum total bilirubin < 1. 5 x upper limit of normal,

alanine aminotransferase or aspartate aminotransferase < 2. 5 x upper limit of normal in the absence of liver metastases, or < 5 x upper limit of normal in the presence of liver metastases.

- Expected life expectancy of greater than 12 weeks in the absence of any intervention

- 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

- Written, informed consent to the study

Exclusion Criteria:

- Medical or psychiatric conditions that compromise the patient's ability to give

informed consent or to complete the protocol or a history of non- compliance

- Last dose of radiotherapy received within 4 weeks before the start of study

treatment, excluding palliative radiotherapy

- Obstruction of gastrointestinal tract

- Active gastrointestinal bleeding

- Myocardial infarction within 6 months prior to the study medication, and other

clinically significant heart disease (e. g., unstable angina, congestive heart failure or uncontrolled hypertension)

- Evidence of severe or uncontrolled systemic disease or any concurrent condition which

in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol

- Female patients who are pregnant or breast-feeding. Female patients must have had a

negative pregnancy test within one week before starting imatinib.

Locations and Contacts

Asan Medical Center, Seoul, Songpa-gu 138-736, Korea, Republic of
Additional Information

Related publications:

Corless CL, Fletcher JA, Heinrich MC. Biology of gastrointestinal stromal tumors. J Clin Oncol. 2004 Sep 15;22(18):3813-25. Review.

Heinrich MC, Corless CL, Demetri GD, Blanke CD, von Mehren M, Joensuu H, McGreevey LS, Chen CJ, Van den Abbeele AD, Druker BJ, Kiese B, Eisenberg B, Roberts PJ, Singer S, Fletcher CD, Silberman S, Dimitrijevic S, Fletcher JA. Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor. J Clin Oncol. 2003 Dec 1;21(23):4342-9.

Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, Heinrich MC, Tuveson DA, Singer S, Janicek M, Fletcher JA, Silverman SG, Silberman SL, Capdeville R, Kiese B, Peng B, Dimitrijevic S, Druker BJ, Corless C, Fletcher CD, Joensuu H. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002 Aug 15;347(7):472-80.

De Giorgi U, Verweij J. Imatinib and gastrointestinal stromal tumors: Where do we go from here? Mol Cancer Ther. 2005 Mar;4(3):495-501. Review.

Verweij J, Casali PG, Zalcberg J, LeCesne A, Reichardt P, Blay JY, Issels R, van Oosterom A, Hogendoorn PC, Van Glabbeke M, Bertulli R, Judson I. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004 Sep 25-Oct 1;364(9440):1127-34.

Debiec-Rychter M, Sciot R, Le Cesne A, Schlemmer M, Hohenberger P, van Oosterom AT, Blay JY, Leyvraz S, Stul M, Casali PG, Zalcberg J, Verweij J, Van Glabbeke M, Hagemeijer A, Judson I; EORTC Soft Tissue and Bone Sarcoma Group; Italian Sarcoma Group; Australasian GastroIntestinal Trials Group. KIT mutations and dose selection for imatinib in patients with advanced gastrointestinal stromal tumours. Eur J Cancer. 2006 May;42(8):1093-103. Epub 2006 Apr 18.

Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38.

Starting date: June 2010
Last updated: June 30, 2015

Page last updated: August 23, 2015

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