NL-OMON56311招募中2 期
A randomised phase II trial of imatinib alternating with;regorafenib compared to imatinib alone for the first line ;treatment of advanced gastrointestinal stromal tumour (GIST) - ALT GIST
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
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. 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 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.
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 PDGFR 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 v4.0 within 4 weeks prior to randomisation., 13. Ongoing infection of
- •> Grade 2 according to CTCAE v4.0., 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 v4.0, 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.<
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