EUCTR2012-002128-33-IT进行中（未招募）不适用
Open-Label, Phase II Study of Trastuzumab in Combination with Lapatinib or Pertuzumab in Combination with Trastuzumab in Patients with HER2-positive Metastatic Colorectal Cancer: the HERACLES Trial (HER2 Amplification for Colo-rectaL Cancer Enhanced Stratification) - Heracles
FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA IRCC DI CANDIOLO0 个研究点开始时间: 2012年7月23日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Subjects must meet all the following inclusion criteria to be eligible for enrolment into the study: 1. Histological/confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery 2. Pathology mandatory requirements: a. the original tumour specimen must be KRAS WT and HER2 IHC 3+ positive, with = 50% positive cells. This criterium is pending confirmation from the ongoing HERACLES DGX validation study. b. the original paraffin block or a minimum of 15 polarized unstained slides from the original paraffin block must be made available to the Pathology Core within 15 days from registration. 3. Age =18 4. ECOG PS 0-1 5. Measurable disease as defined by RECIST 1.1 criteria 6. Progression (PD) while on treatment, or within 6 months from therapy with approved standard drugs 7. Unless otherwise contraindicated patients should have received and failed the following previous therapies for mCRC: fluoropirimidines, oxaliplatin, irinotecan, cetuximab or panitumumab containing regimens. Bevacizumab is allowed 8. Adequate haematological function as defined by: ANC ? 1.5 x 109/L, platelet count ?100 x 109/L, haemoglobin ? 10 g/dL. 9. Adequate renal function, as defined by: creatinine ? 1.5 x UNL 10. Adequate hepatobiliary function, as defined by the following baseline liver function tests: o total serum bilirubin ?1.5 upper normal limit (UNL) o alanine aminotransferase (ALT), aspartate aminotransferase (AST) ? 2.5xUNL o alkaline phosphatase (AP) ? 2.5xUNL; if total alkaline phosphatase (AP) > 2.5xUNL, alkaline phosphatase liver fraction must be ? 2.5xUNL 11. Adequate contraception for all fertile patients 12. Negative pregnancy test.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study: 1. Radiotherapy = 4 weeks prior to enrolment 2. Other chemotherapy or biological therapy treatment = 4 weeks prior to enrolment 3. Symptomatic brain metastases 4. Active infection 5. Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption 6. Impaired cardiac function including any of the following: uncontrolled hypertension (systolic >150 mmHg and/or diastolic > 100 mmHg) or clinically significant (ie active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication; unstable angina; chronic heart failure (CHF) of New York Heart Association (NYHA) Grade II or higher; or serious cardiac arrhythmia requiring medication, baseline Left Ventricular Ejection Fraction (LVEF) = 55% measured by echocardiography (ECHO) 7. Major surgery in the two weeks prior to entering the clinical trial 8. Concurrent treatment with any other anti-cancer therapy 9. History of another neoplastic disease (except basal cell carcinoma of the skin or uterine cervix carcinoma in situ adequately treated), unless in remission for = 5 years 10. Patient unable to comply with the study protocol owing to psychological, social or geographical reasons 11. Pregnant and lactating women 12. Patients with history of hypersensitivity to either IMPs or excipients 13. Men and women of childbearing potential who are not using an effective method of contraception 14. Participation in another clinical trial or treatment with any investigational product within 4 weeks prior to inclusion in this study. 15. Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
研究者
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