Patients With Refractory, Metastatic Cancer Harboring KIT Mutation or Amplification to Investigate the Clinical Efficacy and Safety of Imatinib Therapy
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|ClinicalTrials.gov Identifier: NCT02461849|
Recruitment Status : Active, not recruiting
First Posted : June 3, 2015
Last Update Posted : June 15, 2022
KIT is a receptor tyrosine kinase that binds to stem-cell factor (SCF), activating a series of downstream effector pathways. KIT is an established therapeutic target in cancer with activating mutations of KIT, such as gastrointestinal stromal tumors (GIST), and significant benefit is achieved with various small molecule inhibitors of KIT such as imatinib mesylate. Moreover, there is increasing evidence implicating KIT mutations as tractable therapeutic targets in melanoma. Additional information is required to characterize the functional role of low-frequency mutations in KIT and to determine whether amplification of wild type KIT is a real driver that can be targeted therapeutically. Except GIST and melanoma, other solid cancers were reported to have KIT mutation even in low frequency. A molecular profiling of the tumors of patients referred to the phase I clinic at the M.D. Anderson Cancer Center showed KIT mutation in 7 patients in total of 431 patients (2%).
Hence, the investigators planned this study to apply the molecularly targeted agent, imatinib to various types of cancers harboring KIT mutation or amplification.
|Condition or disease||Intervention/treatment||Phase|
|Advanced, Refractory Cancer||Drug: Imatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-label, Study in Patients With Refractory, Metastatic Cancer Harboring KIT Mutation or Amplification to Investigate the Clinical Efficacy and Safety of Imatinib Therapy|
|Actual Study Start Date :||April 4, 2014|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||December 2022|
Imatinib 400mg qd daily Until disease progression, patient's refusal
Imatinib 400mg qd daily
- Response rate [ Time Frame: expected average of 24 weeks ]Response will be evaluated according to RECIST(Response Evaluation Criteria In Solid Tumors) 1.1 guidelines.Tumor responses will be assessed after the 2cycle chemotherapy and after completion of treatment. They should be classified as complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to the Revised Response Criteria for refractory, metastatic cancer harboring KIT mutation or amplification.
- Duration of response [ Time Frame: expected average of 24 weeks ]
- Progression-free survival [ Time Frame: expected average of 24 weeks ]
- Overall survival [ Time Frame: expected average of 3years ]
- Number of subjects with Adverse Events as a measure of safety [ Time Frame: expected average of 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461849
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|