EUCTR2015-004147-40-IT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 - A clinical trial comparing X-396 (study drug) to Crizotinib in lung cancer patients.
XCOVERY HOLDING COMPANY, LLC0 个研究点目标入组 402 人开始时间: 2021年1月7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
- •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) =1.5 x 109/L
- •b. Platelets =100 x 109/L
- •c. Hemoglobin =9 g/dL (=90 g/L)
- •d. Total bilirubin =1.5 times the upper limit of normal (ULN)
- •e. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
- •=2.5 x ULN if no liver involvement or =5 x ULN with liver involvement.
- •f. Creatinine =1.5 x ULN. If >1.5 x ULN, patient may still be eligible if
- •calculated creatinine clearance =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
- •9. Patients must be =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
- •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 =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
- •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
相似试验
进行中（未招募）
1 期
A clinical trial comparing X-396 (study drug) to Crizotinib in lung cancer patients.on small cell lung cancerMedDRA version: 19.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-004147-40-ESXcovery Holding Company, LLC402
招募中
不适用
XALT3: PHASE 3 RANDOMIZED STUDY COMPARING X-396 TO CRIZOTINIB IN ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS-C34 Malignant neoplasm of bronchus and lungMalignant neoplasm of bronchus and lungC34PER-001-17Xcovery Holding Company, LLC,2
已完成
3 期
Study to find out if restricting raw fruits in patients with blood cancer can reduce infections.CTRI/2018/01/011418Cancer Institute200
已完成
3 期
Steroid tablets for preventing tiredness in cancer patients receiving chemotherapy medicine.CTRI/2018/08/015222Cancer Institute126
进行中（未招募）
1 期
A Randomized Phase III study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete RemissioAcute Myeloid LeukaemiaMedDRA version: 14.1Level: PTClassification code 10000881Term: Acute myeloid leukaemia (in remission)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2007-003514-34-NLEuropean Group for Blood and Marrow trasnplantation231