EUCTR2016-001271-68-GB进行中（未招募）1 期
A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer
Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited0 个研究点目标入组 91 人开始时间: 2019年2月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 91
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
- 性别
- All
入选标准
- •1.Have histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic disease (Stage IIIB or IV). For all cohorts except Expansion Cohort 7, the locally advanced or metastatic disease is NSCLC.
- •2.Must have sufficient tumor tissue available for analysis (see Laboratory Manual for specific requirements). For patients in the expansion cohorts and in the extension cohort, tumor tissue obtained after progression on the most recent prior therapy is preferred.
- •3.Must have measurable disease by RECIST v1.1 (Appendix B).
- •4.Male or female adult patients (aged 18 years or older, or as defined per local regulations).
- •5.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (Appendix A).
- •6.Minimum life expectancy of 3 months or more.
- •7.Adequate renal and hepatic function as defined by the following criteria:
- •a.Total serum bilirubin =1.5 × upper limit of normal (ULN) (=3.0 × ULN for patients with Gilbert syndrome or if liver function abnormalities are due to underlying malignancy);
- •b.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 × ULN (or =5 × ULN if liver function abnormalities are due to underlying malignancy);
- •c.Estimated creatinine clearance =30 mL/min (calculated by using the Cockcroft-Gault equation);
- •d.Serum albumin =2 g/dL; and
- •e.Serum lipase =1.5 × ULN; and
- •f. Serum amylase =1.5 × ULN unless the increased serum amylase is due to salivary isoenzymes.
- •8.Adequate bone marrow function as defined by the following criteria:
- •a.Absolute neutrophil count (ANC) =1.5 × 109/L;
- •b.Platelet count =75 × 109/L; and
- •c.Hemoglobin =9.0 g/dL.
- •9.Normal QT interval on screening electrocardiogram (ECG), defined as QTcF of =450 ms in males or =470 ms in females.
- •10.All toxicities from prior therapy have resolved to = grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0 [18]), or have resolved to baseline, at the time of first dose of TAK 788. Note: treatment-related grade >1 alopecia or treatment-related grade 2 peripheral neuropathy are allowed if deemed irreversible.
- •11.Female patients who:
- •Are postmenopausal for at least 1 year before the screening visit, OR
- •Are surgically sterile, OR
- •If they are of childbearing potential, agree to practice 1 highly effective, nonhormonal method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, OR
- •Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
- •Male patients, even if surgically sterilized (ie, status postvasectomy), who:
- •Agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study drug, OR
- •Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
- •Extension Phase sp
排除标准
- •1.Previously received TAK-788.
- •2.Received small-molecule anticancer therapy (including cytotoxic chemotherapy and investigational agents) =14 days prior to first dose of TAK 788 (except for reversible EGFR TKIs [ie, erlotinib or gefitinib], which are allowed up to 7 days prior to the first dose of TAK 788).
- •3.Received antineoplastic monoclonal antibodies including immunotherapy within 28 days of the first dose of TAK-788.
- •4.Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy. Note: This exclusion criterion does not apply to Expansion Cohort 7.
- •5.Received radiotherapy =14 days prior to the first dose of TAK 788 or has not recovered from radiotherapy-related toxicities. Palliative radiation administered outside the chest and brain, SRS and stereotactic body radiotherapy are allowed up to 7 days prior to the first dose.
- •6.Received a moderate or strong CYP3A inhibitor or strong CYP3A inducer within 10 days prior to first dose of TAK 788 (see Appendix C).
- •7.Have undergone major surgery within 28 days prior to first dose of TAK 788. Minor surgical procedures, such as catheter placement or minimally invasive biopsy, are allowed.
- •8.Have symptomatic CNS metastases at screening or asymptomatic disease requiring corticosteroids to control symptoms within 7 days prior to the first dose of TAK 788.
- •Have known active brain metastases (have either previously untreated intracranial CNS metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions). Brain metastases are allowed if they have been treated with surgery and/or radiation and have been stable without requiring corticosteroids to control symptoms within 7 days before the first dose of TAK-788, and have no evidence of new or enlarging brain metastases.
- •9.Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic).
- •10.Have significant, uncontrolled, or active cardiovascular disease, including, but not restricted to:
- •a.Myocardial infarction (MI) within 6 months prior to the first dose of study drug;
- •b.Unstable angina within 6 months prior to first dose;
- •c.Congestive heart failure (CHF) within 6 months prior to first dose;
- •d.History of clinically significant (as determined by the treating physician) atrial arrhythmia;
- •e.Any history of ventricular arrhythmia; or
- •f.Cerebrovascular accident or transient ischemic attack within 6 months prior to first dose.
- •11.Have a known history of uncontrolled hypertension. Patients with hypertension should be under treatment on study entry to control blood pressure.
- •12.Have prolonged QTcF interval, or being treated with medications known to be associated with the development of Torsades de Pointes (Appendix D).
- •13.(Parts 1 and 2 [dose escalation and expansion cohorts] only) Have an ongoing or active infection including, but not limited to, the requirement for intravenous (IV) antibiotics, or a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Testing is not required in the absence of history.
- •(Part 3 [extension cohort] only) Have an ongoing
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