EUCTR2010-022365-10-AT进行中（未招募）1 期
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects with Locally Advanced or Metastatic, Non-Squamous, Non–Small-Cell Lung Cancer (NSCLC)
Daiichi Sankyo Development Limited0 个研究点目标入组 988 人开始时间: 2011年7月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 988
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. Male or female at least 18 years of age.
- •2. Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous NSCLC.
- •3. Measurable disease and documented disease progression following last prior therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.1.
- •4. Have received one or two prior lines of systemic anti-cancer therapy therapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy. Patients who received only adjuvant treatment will be eligible only if disease progression occurred <6 months after completion of adjuvant therapy. Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued without discontinuation after initiation of a treatment regimen.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •6. Resolution of any toxic effects of prior therapy (including radiotherapy) according to NCI CTCAE, Version 4.0, Grade =1 (with the exception of alopecia and = Grade 2 neuropathy). Subject must have recovered from significant surgery-related complications.
- •7. Demonstrate adequate bone marrow, liver, and renal functions, defined as:
- •ALT, AST, and alkaline phosphatase = 2.5 × upper limit of normal (ULN) in subjects with no liver metastasis and =5.0 x ULN in subjects with liver metastasis.
- •Total bilirubin = 1.5 × ULN (= 4 × ULN total and =1.5 × ULN direct bilirubin is acceptable for subjects with Gilbert’s syndrome).
- •ANC =1.5 × 10e9/L.
- •Platelet count =100 × 10e9/L.
- •Hemoglobin =9.0 g/dL (transfusion and/or growth factor support allowed).
- •Serum creatinine =1.5 × ULN or creatinine clearance = 60 mL/min.
- •8. Archival and/or fresh biopsy tissue sample must be available for biomarker determination. The status of the following biomarkers will be collected in this study: EGFR and KRAS mutation status prior to randomization, and MET status post randomization:
- •a. Previously existing documentation for EGFR and KRAS mutation status from an accredited local laboratory (ie, certified by CLIA, CAP and/or similar agencies) will be accepted.
- •b. If documented results are not available, then archival and/or fresh tissue biopsy samples (approximately 10 unstained, unbaked, uncharged, paraffinembedded slides) or a tissue block suitable for biomarker analysis must be available.
- •c. If EGFR and KRAS data from local laboratories are utilized, tissue samples for MET IHC and FISH analysis must be provided to the central lab. Refer to the lab manual for further details on sample requirements.
- •d. If a subject does not have previous documentation or adequate tissue for EGFR status determination, the subject is not eligible for the study.
- •9. If of child-bearing/reproductive potential (female or male), must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received.
- •10. If female and of childbearing potential, must have a negative result of a pregnancy test (serum or urine) within 72 hours prior to initiating study treatment.
- •11. Must have signed and dated an IEC or IRB approved ICF (Including HIPAA authorization, if applicable) before performance of any study-specific procedures or tests. Subjects must be fully informed about their illness and the investigational nature of the study protocol (includ
排除标准
- •1. Prior therapy with an EGFR inhibitor and/or ARQ 197 (or other known c-MET inhibitor).
- •2. Receipt of any systemic anti-tumor treatment for NSCLC within 3 weeks prior to randomization.
- •3. Receipt of palliative radiotherapy within 2 weeks or radiotherapy for curative intent of target lesions within 3 weeks prior to randomization. (Lesions subjected to radiotherapy within 3 weeks prior to randomization may not be used as target lesions.)
- •4. Major surgical procedure within 3 weeks prior to randomization (brain
- •metastases treated with sterotactic gamma knife radiosurgery within 3 weeks prior to randomization will be allowed).
- •5. History of cardiac disease:
- •Congestive heart failure defined as Class II to IV per New York Heart Association classification; active coronary artery disease; previously diagnosed symptomatic bradycardia (subjects with asymptomatic bradycardia and heart rate above 50 bpm are allowed) or other cardiac arrhythmia defined as =Grade 2 according to NCI CTCAE, version 4.0, or uncontrolled hypertension; myocardial infarction that occurred within 6 months prior to study entry (myocardial infarction that occurred > 6 months prior to study entry is permitted).
- •6. Clinically unstable CNS metastasis (to be enrolled in the study, subjects must have confirmation of stable disease by MRI or computed tomography (CT) scan within 4 weeks of randomization and have CNS metastases well controlled by steroids, anti-epileptics or other symptom-relieving medications).
- •7. Need to breastfeed a child during or within 12 weeks of completing the study.
- •8. Significant gastrointestinal disorder that, in the opinion of the investigator, could interfere with absorption of ARQ 197 and/or erlotinib (eg, Crohn’s disease, small or large bowel resection, malabsorption syndrome).
- •9. Inability or unwillingness to swallow the complete doses of ARQ 197 or erlotinib.
- •10. Any known contraindication to treatment with, including hypersensitivity to, ARQ 197 or erlotinib.
- •11. History of malignancy other than NSCLC within the 5 years prior to randomization, with the exceptions of adequately treated intraepithelial carcinoma of the cervix uteri; prostate carcinoma with a prostate-specific antigen value <0.2 ng/mL; or basal or squamous-cell carcinoma of the skin.
- •12. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •13. Any other significant co-morbid condition that, in opinion of the investigator, would impair study participation or cooperation.
研究者
相似试验
进行中（未招募）
1 期
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitislcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856MedDRA version: 20.1Level: LLTClassification code 10045366Term: Ulcerative colitis, unspecifiedSystem Organ Class: 100000004856EUCTR2018-003985-15-PTArena Pharmaceuticals Inc.433
进行中（未招募）
1 期
A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisEUCTR2019-000968-18-CZCB Biopharma SR240
进行中（未招募）
1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based ChemotherapyHomologous recombination deficiency advanced ovarian cancerMedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-000952-11-ITTESARO, INCORPORATED733
进行中（未招募）
1 期
A Clinical trial to evaluate safety, and effectiveness of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)EUCTR2016-004148-13-PTGilead Sciences, Inc.800
招募中
1 期
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants with Advanced/Metastatic Non-Small Cell Lung Cancerung Cancer, Non-Small CellMedDRA version: 21.1Level: PTClassification code: 10029521Term: Non-small cell lung cancer stage IIIB Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10029522Term: Non-small cell lung cancer stage IV Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864CTIS2023-508443-40-00Glaxosmithkline Research & Development Limited644