NL-OMON53126招募中2 期
A randomized phase II study of pulsatile high-dose sunitinib versus TAS-102 in patients with metastatic colorectal carcinoma (mCRC). - SUNRISE-CRC
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
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
- •To be eligible for this trial, patients will need to meet all of the following
- •inclusion criteria. Screening must be performed no more than 14 days prior to
- •the first study drug dose., 1: Signed (by the patient or legally acceptable
- •representative) and dated Informed Consent Form (ICF). , 2: Histological or
- •cytological confirmed, documentation of incurable locally advanced or
- •metastatic, colorectal adenocarcinoma, not amenable for potentially curative
- •treatment (i.e. inoperable).
- •3: Indication for treatment with TAS-102; progressive on (or intolerant to)
- •therapy including fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy
- •and anti-EGFR therapy (for tumours with wild-type RAS, BRAF and a left sided
- •tumour)). , 4: Evaluable disease by RECIST version 1.1 criteria (see appendix
- •III)., 5: Age >= 18 years. , 6: Eastern Cooperative Oncology Group (ECOG)
- •Performance Status of 0-2., 7: Normal 12-lead ECG (clinically insignificant
- •abnormalities permitted)., 8: No signs of clinical thyroid abnormalities
- •(suppletion or blocking drugs permitted)., 9: Adequate bone marrow function;
- •hemoglobin > 5.6 mmol/l, absolute neutrophil count (ANC) > 1,5 x 10*9/l,
- •Platelet count *> 100 x 10*9/l, , 10: Adequate liver function; total bilirubin<
- •1.5 times the upper limit of normal (ULN), ALT and AST < 2.5 x ULN (In case of
- •liver metastases: <; 5 x ULN)., 11: Albumin higher than 25 g/L, 12: Serum
- •creatinine <;1.5 x ULN or creatinine clearance * 50 ml/min/1.73m2 (based on
- •MDRD)., 13: Pregnant or breast-feeding subjects: Women of childbearing
- •potential must have a negative pregnancy test performed within 7 days of the
- •start of treatment. For fertile men or women of childbearing potential:
- •documented willingness to use a highly effective means of contraception (e.g.,
- •hormonal methods [implants, injectables, or combined oral contraceptives],
- •intrauterine devices, sexual abstinence, or vasectomized or surgically
- •sterilized partner). Contraception is necessary for at least 6 months after
- •receiving the study medication.
排除标准
- •The following criteria exclude the patient from enrollment in this trial, 1:
- •Previous treatment with sunitinib and/or TAS-102 for mCRC., 2: Evidence of
- •significant uncontrolled concomitant disease, such as cardiovascular disease
- •(including stroke, New York Heart Association Class III or IV cardiac disease
- •or myocardial infarction within 6 months prior to screening, unstable
- •arrhythmia, clinically significant valvular heart disease and unstable angina);
- •pulmonary disease (including obstructive pulmonary disease > GOLD 2 and
- •inadequately treated symptomatic bronchospasm), and uncontrolled central
- •nervous system, renal, hepatic, endocrine, or gastrointestinal disorders; or a
- •serious non-healing wound or fracture., 3: Extensive prior radiotherapy in the
- •rectum, pelvis or in more than 3 vertebrae in the spine (less than 3 vertebrae
- •are considered a small radiation field and eligibility will be decided on an
- •individual basis from the PI)., 4: Poorly controlled hypertension despite
- •adequate blood pressure medication. Blood pressure must be <=160/95 mmHg at the
- •time of screening on a stable antihypertensive regimen. Blood pressure must be
- •stable on at least 2 separate measurements., 5: Instable seizure disorders
- •requiring anticonvulsant therapy., 6: Major surgery, other than diagnostic
- •surgery, within 4 weeks prior to day 1, without complete recovery., 7:
- •Uncontrolled bleeding disorders, and/or active bleeding., 8: Known active
- •bacterial, viral, fungal, mycobacterial, or other infection. (including HIV and
- •atypical mycobacterial disease, but excluding fungal infection of the nail
- •beds.), 9: Known hypersensitivity to sunitinib, TAS-102, or to its excipients.,
- •10: Presence of any significant psychiatric disorder(s) that would interfere
- •with the patient*s compliance., 11: Chemotherapy, radiotherapy, or other
- •anti-cancer therapy within the previous 4 weeks; no nitrosoureas or mitomycin C
- •within the previous 6 weeks; no investigational agents within the previous 4
- •weeks., 12: Clinically significant history of liver disease, including viral or
- •other hepatitis, current alcohol abuse, or cirrhosis., 13: Untreated or active
- •central nervous system (CNS) metastases., 14: Predisposing colonic or small
- •bowel disorders in which the symptoms are uncontrolled as indicated by baseline
- •of >3 loose stools daily despite medication., 15: Unresolved bowel obstruction,
- •16: Any evidence of a disease or condition that might affect compliance with
- •the protocol or interpretation of the study results or render the patient at
- •high risk from treatment complications.
研究者
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