Clinical Trials List
2015-09-01 - 2018-03-31
Phase II
Terminated6
ICD-10C34
Malignant neoplasm of bronchus and lung
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
A phase 2, parallel group, to explore the study of MGCD265 in patients with locally advanced or metastatic non-small cell lung cancer with active gene mutations in mesenchymal-epithelial transforming factor
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Trial Applicant
Pharmaceutical Research Associates Taiwan Inc.
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Sponsor
Mirati Therapeutics, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Jui-Ying Lee 無
- 李玫萱 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Wen-Pin Su Division of Hematology & Oncology
- Chien-Chung Lin Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- Seu-Chun Yang Division of Hematology & Oncology
- Yu-Min Yeh Division of Hematology & Oncology
- Sin-Syue Li Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
1. Histological examination confirmed NSCLC with metastatic or unresectable locally advanced disease in the body.
2. Have previously received at least one therapy in the context of suffering from advanced disease.
3. Using methods and laboratories approved by the test client to perform molecular analysis on the specimens obtained from the patients, the results showed that the tumor tissue and/or ctDNA contained genetic mutation activated MET gene. If the test qualification is established by a local laboratory, it is expected that there should be tumor tissue samples and/or DNA available for retrospective sequencing by the central laboratory selected by the test client; if the minimum amount is included, the central laboratory can be used There are no tumor specimens under review, and it is not safe to perform a new tissue section, so the patient should be admitted only after the approval of the trial client.
4. According to the definition of RECIST Version 1.1, there are measurable lesions in the body.
5. The United States East Coast Cancer Research Cooperative Group (ECOG) physical status is 0, 1, or 2 points).
6. Sufficient bone marrow and organ functions are confirmed by the following conditions:
a. Absolute neutrophil count ≥ 1,000/mm3 (≥ 1.0 × 109/L)
b. alanine transaminase (ALT) and Aspartate transaminase (AST) ≤ 2.5 × upper limit of normal (ULN); if it is a patient with confirmed liver metastasis, It is ≤ 5.0 x ULN. Alkaline phosphoric acid concentration≤ 2.5 × ULN. If there is extensive bone metastasis, there is no upper limit for alkaline phosphate.
c. Total bilirubin ≤ 1.5 x ULN; if it is Gilbert's syndrome or patients with confirmed liver metastasis, it is≤ 3.0 x ULN.
7. Age ≥ 18 years old.
8. Women with fertility (women of child-bearing potential, WOCBP), or men whose partner is WOCBP, agree to continue contraception during the trial period and 6 months after the trial treatment stops.
9. The informed consent procedure has been completed, including signing the subject consent form approved by the Human Testing Board (IRB)/Ethics Committee (EC).
10. Willing to comply with clinical trial instructions and regulations.
Exclusion Criteria
1. Previously received treatment with MET or HGF small molecule or antibody inhibitor.
2. The previous EGFR gene mutation or ALK gene recombination test results were positive.
3. The time when the last chemotherapy or investigational drug was discontinued was 2 weeks before the first dose of the trial drug.
4. When entering the trial, the adverse reactions left by the previous treatment have not yet recovered to ≤ Level 2 (excluding hair loss).
5. A history of stroke or transient ischemic attack in the past 6 months.
6. Suffer from any of the following heart abnormalities:
a. Unstable angina,
b. ≥ New York Heart Association (NYHA) grade 3 congestive heart failure, or
c. QTc interval> 480 msec.
7. Known or suspected of having other cancers that may be mistaken for metastatic NSCLC during disease evaluation.
8. Suffer from a brain metastasis that currently requires treatment and is symptomatic or uncontrolled (less than 4 weeks from the last head radiotherapy or less than 2 weeks from the last steroid treatment). Certain conditions are known to have a significant risk of intracranial hemorrhage, including but not limited to vascular malformations and pituitary adenomas.
9. Unable to swallow oral drugs, or have gastrointestinal disorders that may interfere with the normal absorption of oral drugs.
10. Known to be allergic to any component of MGCD265 medicine.
11. In pregnancy. WOCBP must obtain a negative result in a serum or urine pregnancy test during the screening period before starting to use the test drug.
12. Currently breastfeeding or planning to breastfeed during the trial period or within 6 months after trial treatment.
13. Suffer from any serious disease, uncontrolled disease that occurred during the trial, active or uncontrolled infection, or other medical history (including laboratory test results), which is determined by the trial host to be likely to interfere with the patient Participation in trials or interpretation of trial results.
The Estimated Number of Participants
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Taiwan
35 participants
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Global
290 participants
