NL-OMON49519已完成不适用
A Phase 1, Open-Label, Multicenter, Drug-Drug Interaction Study of TAK-788 and Midazolam, a Sensitive CYP3A Substrate, in Patients With Advanced Non*Small Cell Lung Cancer - Drug-Drug Interaction Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female patients aged *18 years.
- •2. Histologically or cytologically confirmed locally advanced NSCLC in which
- •the patient is not a candidate for definitive therapy; or, the patient has
- •recurrent or metastatic (Stage IV) disease.
- •3. Refractory or intolerant to standard available therapies.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- •5. Minimum life expectancy of 3 months or more.
- •6. Adequate organ function as defined by the protocol criteria.
- •a) Total serum bilirubin *1.5 × upper limit of normal (ULN) (*3 × ULN for
- •patients with Gilbert syndrome or if liver function abnormalities are due to
- •underlying malignancy);
- •b) Alanine aminotransferase and aspartate aminotransferase *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;
- •e) Serum lipase *1.5 × ULN; and
- •f) Serum amylase *1.5 × ULN unless the increased serum amylase is due to
- •salivary isoenzymes.
- •7. Adequate bone marrow function, as defined by the protocol criteria.
- •a) Absolute neutrophil count *1.5 × 109/L;
- •b) Platelet count *75 × 109/L; and
- •c) Hemoglobin *9.0 g/dL.
- •8. Normal QT interval on screening ECG, defined as QTcF of *450 msec in males
- •or *470 msec in females. (as conducted and interpreted in accordance to local
- •institutional practices and confirmed by PI).
- •9. All toxicities from prior anticancer therapy must have resolved to *Grade 1
- •according to the NCI CTCAE version 5.0 [1], or have resolved to baseline, at
- •the time of first dose of TAK-788. Note: treatment-related Grade 2 or 3
- •alopecia and treatment-related Grade 2 peripheral neuropathy are allowed if
- •deemed irreversible.
- •10. Female patients who are of childbearing potential, agree to comply with
- •protocol-defined contraception criteria or practice true abstinence.
- •11. Male patients 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.
- •12. If female, a negative serum or urine pregnancy test result during the
- •screening period.
- •13. Suitable venous access for study-required blood sampling (ie, including for
- •PK, pharmacodynamics, and clinical laboratory tests).
- •14. Willingness and ability to comply with scheduled visits and study
- •procedures.
- •15. Signed and dated the informed consent indicating that the patient has been
- •informed of all pertinent aspects of the study. Voluntary written consent must
- •be given before performance of any study-related procedure not part of standard
- •medical care, with the understanding that consent may be withdrawn by the
- •patient at any time without prejudice to future medical care.
排除标准
- •1. Previously received TAK-788.
- •2. Received a strong or moderate CYP3A inhibitor or strong or moderate CYP3A
- •inducer within 2 weeks prior to the first dose of TAK-788.
- •3. Received small-molecule anticancer therapy (including but not limited to
- •cytotoxic chemotherapy and investigational agents) within 2 weeks prior to the
- •first dose of TAK-788.
- •4. Received antineoplastic monoclonal antibodies including check point
- •inhibitors within 28 days of the first dose of TAK-788.
- •5. Received radiotherapy *14 days prior to the first dose of TAK-788. However,
- •patients are allowed to receive any of the following treatments up to 7 days
- •prior to the first dose: (a) Stereotactic radiosurgery (SRS), (b) stereotactic
- •body radiation therapy (SBRT), or (c) palliative radiation outside the chest
- •6. Major surgery within 28 days prior to the first dose of TAK-788. Minor
- •surgical procedures, such as catheter placement or minimally invasive biopsy,
- •are allowed.
- •7. 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 another primary
- •malignancy and is definitively relapse-free with at least 3 years elapsed since
- •the diagnosis of the other primary malignancy.
- •8. 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. Current spinal cord compression (symptomatic or asymptomatic and detected by
- •radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic).
- •10. Have uncontrolled hypertension. Patients with hypertension should be under
- •treatment on study entry to control blood pressure.
- •11. Significant, uncontrolled, or active cardiovascular disease.
- •12. Treatment with medications known to be associated with the development of
- •torsades de pointes.
- •13. Current or history of interstitial lung disease, radiation pneumonitis that
- •required steroid treatment, or drugrelated pneumonitis.
- •14. Ongoing or active infection including, but not limited to, the requirement
- •for IV antibiotics, or a known history of human immunodeficiency virus
- •infection. Testing is not required in the absence of history. Patients who are
- •positive for hepatitis B surface antigen or anti-hepatitis C virus antibody may
- •be eligible (see full protocol for further details).
- •15. Gastrointestinal illness or disorder that could affect oral absorption of
- •TAK-788 or midazolam.
- •16. If female, the patient is lactating and breastfeeding. Female patients who
- •are lactating will be eligible if they discontinue breastfeeding.
- •17. History of, or suspected, hypersensitivity or allergy to midazolam or its
- •excipients or TAK-788.
- •18. Any condition or illness that, in the opinion of the investigator, might
- •compromise patient safety or interfere with the evaluation of the safety of the
- •study drug.
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