EUCTR2015-001298-42-SK进行中（未招募）1 期
A randomised phase II trial of imatinib alternating withregorafenib compared to imatinib alone for the first line treatment of advanced gastrointestinal stromal tumour (GIST) - ALT GIST
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 76 人开始时间: 2015年9月10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
- 76
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. Adults (over 18 yrs) with histologically confirmed GIST. In CD-117-negative cases DOG-1 must be positive or a KIT/PDGFRA mutation must be present.
- •2. Unresectable, metastatic disease.
- •3. No prior TKI for metastatic disease, with the exception of those patients who have had up to and including 21 days of uninterrupted treatment on 400mg daily of imatinib.
- •4. Imatinib therapy given as an adjuvant treatment and completed at least 3 months prior to entry into this trial is permitted. Patients who have progression of GIST while on adjuvant therapy are not eligible for this trial.
- •5. ECOG performance status 0-2
- •6. Measurable disease by RECIST version 1.1. (Note: Participants with only peritoneal disease will be eligible only if they have lesions measurable in two dimensions and have at least 1 lesion
- •which is = 2 cm in size).
- •7. Adequate bone marrow function (Haemoglobin = 9.0g/dL, platelet count = 100 x 109/L, and absolute neutrophil count = 1.5 x 109/L).
- •8. Adequate liver function (Serum total bilirubin =1.5 x ULN, INR = 1.5, and ALT, AST, ALP =2.5 x ULN (= 5 x ULN for participants with liver metastases). Lipase level must be = 1.5 x ULN.
- •9. Adequate renal function (Creatinine clearance > 50ml/min) based on either the Cockcroft Gault formula, 24 hour urine or Glomerular Filtration Rate (GFR scan); and serum creatinine = 1.5 x ULN.
- •10. Tumour tissue available for central review.
- •11. Willing and able to comply with all study requirements, including treatment timing and/or nature of required assessments.
- •12. Study treatment both planned and able to start within 14 days of randomisation.
- •13. Signed, 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 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •1. Concurrent GI illness which may prevent absorption of imatinib or regorafenib – please note that prior gastrectomy or bowel resection does not exclude patients from this study.
- •2. Use of other investigational drugs within 4 weeks prior to enrolment.
- •3. Known sensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
- •4. Participants receiving therapeutic doses of warfarin.
- •5. Presence of brain metastases.
- •6. The presence of known PDGFRA D842V mutation or other mutation known to cause imatinib resistance.
- •7. Inability to swallow tablets.
- •8. Arterial thrombotic or ischaemic events, such as cerebrovascular accident or pulmonary embolism within 6 months prior to randomisation; or major venous thrombotic events requiring use of an anticoagulant such as warfarin within 6 months prior to randomisation.
- •9. Poorly controlled hypertension (systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
- •10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomisation, or non healing wound, ulcer or fracture.
- •11. Congestive cardiac failure (NYHA = grade 2), unstable angina or new onset angina within the previous 3 months, or AMI within the previous 6 months. Cardiac arrhythmias requiring antiarrhythmic
- •therapy (beta blockers or digoxin are permitted).
- •12. Haemorrhage or bleeding event = Grade 3 according to CTCAE v4.03 within 4 weeks prior to randomisation.
- •13. Ongoing infection of > Grade 2 according to CTCAE v4.03.
- •14. Active hepatitis B or C or HIV, or chronic hepatitis B or C requiring treatment with antiviral therapy. Testing for these is not mandatory unless clinically indicated.
- •15. Interstitial lung disease with ongoing signs and symptoms.
- •16. Persistent proteinuria of = Grade 3 (>3.5g/24 hours) according to CTCAE v4.03
- •17. Other significant medical or psychiatric condition judged by the investigator to interfere with protocol requirements.
- •18. Use of biological response modifiers such as granulocyte colony stimulating factor (G-CSF), within 3 weeks prior to randomisation.
- •19. Patients taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinovir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg carbamazepine, phenobarbitol, phenytoin, rifampicin, St John’s wort).
- •20. History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible.
- •Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment.
- •21. Pregnancy, lactation, or inadequate contraception. Women must be post menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a
- •negative pregnancy test done within 7 days prior to registration. Women of childbearing potential and men must agree to use adequate contraception before entering the trial until at
- •least 8 weeks after the last study drug administration.
研究者
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