EUCTR2015-002070-21-HU进行中（未招募）1 期
Phase 2, Parallel-Arm Study of MGCD265 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Activating Genetic Alterations in Mesenchymal-Epithelial Transition Factor
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 290
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Histologically confirmed NSCLC with metastatic or unresectable, locally advanced disease.
- •2. Receipt of at least one prior platinum-containing chemotherapy regimen in the advanced disease setting.
- •3. Molecular analysis of patient-derived samples using a Sponsor approved method and laboratory that demonstrates a genetic alteration activating MET in tumor tissue and/or ctDNA. If eligibility is established using a Sponsor-approved local laboratory, a tumor tissue specimen and/or blood sample is expected to be available for retrospective sequencing in the central laboratory selected by the Sponsor.
- •4. Measurable disease, as per RECIST version 1.1.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- •6. Adequate bone marrow and organ function demonstrated by:
- •-Absolute neutrophil count = 1,000/mm3 (= 1.0 × 109/L)
- •-Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 × Upper Limit of Normal (ULN), or = 5.0 x ULN for patients with documented liver metastases. Alkaline phosphatase levels = 2.5 × ULN. In the presence of extensive bone metastases, there is no upper limit for alkaline phosphatase.
- •-Total bilirubin = 1.5 x ULN or = 3.0 x ULN for patients with Gilbert Syndrome or documented liver metastases.
- •7. = 18 years of age.
- •8. Women of child-bearing potential (WOCBP) or men whose partner is a WOCBP agrees to use contraception while participating in this study, and for a period of 6 months following termination of study treatment.
- •9. Completed informed consent process, including signing IRB/EC-approved informed consent form.
- •10. Willing to comply with clinical trial instructions and requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •1. Prior treatment with a small molecule or antibody inhibitor of MET or HGF.
- •2. Prior positive test for EGFR mutation or ALK gene rearrangement:
- •-Testing and documentation is required for patients with adenocarcinoma histology
- •Testing is not required for patients with non-adenocarcinoma histology; however if documentation of a positive test is available, the patient will not be eligible
- •3. Most recent prior chemotherapy or investigational agent discontinued =2 weeks before first dose date.
- •4. Absence of recovery from the adverse effects of prior therapy at the time of enrollment to = Grade 2 (excluding alopecia).
- •5. History of stroke or transient ischemic attack within the previous 6 months.
- •6. Any of the following cardiac abnormalities:
- •-Unstable angina pectoris,
- •-Congestive heart failure = NYHA Class 3, or
- •-QTc > 480 msec.
- •7. Known or suspected presence of another malignancy that could be mistaken for metastatic NSCLC during disease assessments.
- •8. Symptomatic or uncontrolled brain metastases requiring current treatment (less than 4 weeks from last cranial radiation or 2 weeks from last steroids). Known conditions associated with significant risk of intracranial bleeding including but not limited to vascular malformations and pituitary adenoma.
- •9. Inability to swallow oral medications or pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs.
- •10. Known hypersensitivity to any of the components of the MGCD265 Drug Product.
- •11. Pregnancy. WOCBP must have a negative serum or urine pregnancy test documented within the screening period prior start of study drug.
- •12. Breast-feeding or planning to breast feed during the study or within 6 months after study treatment.
- •13. Any serious illness, uncontrolled inter-current illness, active or uncontrolled infection, or other medical history, including laboratory results, which, in the Investigator’s opinion, would be likely to interfere with the patient’s participation in the study, or with the interpretation of the results.
研究者
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