EUCTR2015-004147-40-ES进行中（未招募）1 期
Phase 3, Randomized Study Comparing X-396 to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients
Xcovery Holding Company, LLC0 个研究点目标入组 402 人开始时间: 2016年6月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 402
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. Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana IHC assay. Patients may have received up to 1 prior chemotherapy regimen, which may also include maintenance therapy.
- •2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2.
- •3. Life expectancy of at least 12 weeks.
- •4. Ability to swallow and retain oral medication.
- •5. Adequate organ system function, defined as follows:
- •a. Absolute neutrophil count (ANC) > or = 1.5 x 109/L
- •b. Platelets > or =100 x 109/L
- •c. Hemoglobin > or =9 g/dL (> or =90 g/L)
- •d. Total bilirubin < or =1.5 times the upper limit of normal (ULN)
- •e. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < or =2.5 x ULN if no liver involvement or < or =5 x ULN with liver involvement.
- •f. Creatinine < or =1.5 x ULN. If >1.5 x ULN, patient may still be eligible if calculated creatinine clearance > or =50 mL/min (0.83 mL/s) as calculated by the Cockcroft-Gault method.
- •6. Brain metastases allowed if asymptomatic at study baseline. Patients with untreated brain metastases must not be on corticosteroids. If patients have
- •neurological symptoms or signs due to CNS metastases, patients need to complete whole brain radiation or focal treatment at least 14 days before start of study treatment and be asymptomatic on stable or decreasing doses of corticosteroids at baseline.
- •7. Men willing to use adequate contraceptive measures.
- •8. Women who are not of child-bearing potential, and women of child-bearing potential who agree to use adequate contraceptive measures and who have
- •a negative serum or urine pregnancy test within 1 week prior to initial trial treatment.
- •9. Patients must be > or = 18 years of age.
- •10. Patients must have measurable disease per RECIST v. 1.1.
- •11. Patients must be ALK-positive by IHC. Testing will be done centrally;
- •however, patients will be allowed to enroll based on local results (positive by FISH or IHC), if available.
- •12. Willingness and ability to comply with the trial and follow-up procedures.
- •13. Ability to understand the nature of this trial and give written informed consent.
- •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 302
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Patients that have previously received an ALK TKI, and patients currently receiving cancer therapy (i.e., other targeted therapies, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization).
- •2. Use of an investigational drug within 21 days prior to the first dose of study drug. Note that to be eligible, any drug-related toxicity should have recovered to Grade 1 or less, with the exception of alopecia.
- •3. Any chemotherapy within 4 weeks, or major surgery or radiotherapy within the last 14 days.
- •4. Patients with primary CNS tumors and leptomeningeal disease are ineligible.
- •5. Patients with a previous malignancy within the past 3 years (other than curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, or any cancer that is considered to be cured and have no impact on PFS and OS for the current NSCLC).
- •6. Concomitant use of drugs with a risk of causing Torsades de Pointes within 14 days prior to starting study drug.
- •7. Concomitant use of herbal medications. These should be stopped prior to study entry.
- •8. Patients receiving strong CYP3A inhibitors or inducers.
- •9. Women who are pregnant or breastfeeding.
- •10. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
- •11. Clinically significant cardiovascular disease including:
- •a. QTcF interval > o = 450 ms, symptomatic bradycardia <45 beats per minute or other significant ECG abnormalities in the investigator’s opinion.
- •b. Clinically uncontrolled hypertension in the investigator’s opinion (e.g., blood pressure >160/100 mmHg; note that isolated elevated readings considered to not be indicative of uncontrolled hypertension are allowed).
- •The following within 6 months prior to Cycle 1 Day 1:
- •a. Congestive heart failure (New York Heart Class III or IV).
- •b. Arrhythmia or conduction abnormality requiring medication. Note: patients with atrial fibrillation/flutter controlled by medication and arrhythmias controlled by pacemakers are eligible.
- •c. Severe/unstable angina, coronary artery/peripheral bypass graft, or myocardial infarction.
- •d. Cerebrovascular accident or transient ischemia.
- •12. Patients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have interstitial lung disease/pneumonitis, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment. Patients with controlled hepatitis C, in the investigator’s opinion, are allowed. Patients with known hepatitis B must be HBeAg and HB viral DNA negative for enrollment. Note that, because of the high prevalence, all patients in the Asia-Pacific region (except Australia, New Zealand, and Japan) must be tested and, if HBsAg positive, must be HBeAg and HB viral DNA negative for enrollment.
- •13. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- •14. Concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled.
- •15. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
研究者
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