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Patients With Refractory, Metastatic Cancer Harboring KIT Mutation or Amplification to Investigate the Clinical Efficacy and Safety of Imatinib Therapy

Primary Purpose

Advanced, Refractory Cancer

Status

Active

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Imatinib

About this trial

This is an interventional treatment trial for Advanced, Refractory Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age ≥ 20
advanced, refractory cancer patients who failed standard of care (SOC)
KIT aberration: defined as mutation in exons 9, 11, 13, 17 or 18, or nanostring CNV by quantitative PCR (greater than 3 copies) or subject with specific sensitivity (Z-score<-1) to imatinib by Avatar scan whose disease has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy
ECOG performance status of 0~2
measurable or evaluable lesion per RECIST 1.1 criteria
adequate marrow, hepatic, renal and cardiac functions
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
- Total serum bilirubin ≤ 1.5 x ULN
- Absolute neutrophil count(ANC) ≥ 1,500/uL
- Platelets ≥ 100,0000/uL
- Hemoglobin ≥ 9.0 g/dL
provision of a signed written informed consent

Exclusion Criteria:

severe co-morbid illness and/or active infections
pregnant or lactating women
history of major surgery or radiotherapy within 4 weeks
active CNS metastases not controllable with radiotherapy or corticosteroids (however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
known history of hypersensitivity to study drugs

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imatinib

Arm Description

Imatinib 400mg qd daily Until disease progression, patient's refusal

Outcomes

Primary Outcome Measures

Response rate

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.

Secondary Outcome Measures

Duration of response

Progression-free survival

Overall survival

Number of subjects with Adverse Events as a measure of safety

Full Information

NCT ID

NCT02461849

First Posted

May 28, 2015

Last Updated

June 13, 2022

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02461849

Brief Title

Patients With Refractory, Metastatic Cancer Harboring KIT Mutation or Amplification to Investigate the Clinical Efficacy and Safety of Imatinib Therapy

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 4, 2014 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced, Refractory Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Imatinib

Arm Type

Experimental

Arm Description

Imatinib 400mg qd daily Until disease progression, patient's refusal

Intervention Type

Drug

Intervention Name(s)

Imatinib

Intervention Description

Imatinib 400mg qd daily

Primary Outcome Measure Information:

Title

Response rate

Description

Time Frame

expected average of 24 weeks

Secondary Outcome Measure Information:

Title

Duration of response

Time Frame

expected average of 24 weeks

Title

Progression-free survival

Time Frame

expected average of 24 weeks

Title

Overall survival

Time Frame

expected average of 3years

Title

Number of subjects with Adverse Events as a measure of safety

Time Frame

expected average of 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age ≥ 20 advanced, refractory cancer patients who failed standard of care (SOC) KIT aberration: defined as mutation in exons 9, 11, 13, 17 or 18, or nanostring CNV by quantitative PCR (greater than 3 copies) or subject with specific sensitivity (Z-score<-1) to imatinib by Avatar scan whose disease has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy ECOG performance status of 0~2 measurable or evaluable lesion per RECIST 1.1 criteria adequate marrow, hepatic, renal and cardiac functions Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin ≤ 1.5 x ULN Absolute neutrophil count(ANC) ≥ 1,500/uL Platelets ≥ 100,0000/uL Hemoglobin ≥ 9.0 g/dL provision of a signed written informed consent Exclusion Criteria: severe co-morbid illness and/or active infections pregnant or lactating women history of major surgery or radiotherapy within 4 weeks active CNS metastases not controllable with radiotherapy or corticosteroids (however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid) known history of hypersensitivity to study drugs

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Patients With Refractory, Metastatic Cancer Harboring KIT Mutation or Amplification to Investigate the Clinical Efficacy and Safety of Imatinib Therapy

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