EUCTR2012-004369-42-GB进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Phase-III Study of Adjuvant Regorafenib Versus Placebo for Patients with Stage IV Colorectal Cancer After Curative Treatment of Liver Metastases - (COAST)
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
- Bayer AG
- 入组人数
- 25
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
入选标准
- •Eligible subjects must:
- •1. Be male or female, and = 18 years of age
- •2. Have a history of a primary adenocarcinoma of the colon and / or
- •3. Have a history of Stage IV CRC with metastases to the liver only
- •4.Have received at least 3 months of neoadjuvant, adjuvant, or perioperative chemotherapy, including a fluoropyrimidine and either oxaliplatin or irinotecan or both for subjects with initial Stage IV CRC which were treated with surgery with curative intent for both primary and metastatic lesions. The total chemotherapy administered, including
- •that administered prior to and after liver resection, should not exceed 9 months.
- •Have received surgery with curative intent for primary CRC and at least 3 months of neoadjuvant, adjuvant, or perioperative chemotherapy for the primary tumor, including a fluoropyrimidine or a fluoropyrimidine and either oxaliplatin or irinotecan or both
- •For subjects with liver metastases developing > 6 months after completing treatment for primary CRC and having undergone surgery with curative intent for liver metastases, a second course of chemotherapy lasting at least 3 months needs to be administered,
- •including a fluoropyrimidine and either oxaliplatin or irinotecan or both. The second course of chemotherapy should not exceed 9 months.
- •For subjects who developed liver metastases = 6 months after completing treatment for primary CRC and having undergone surgery with curative intent for liver metastases, a second course of chemotherapy is not permitted unless initial adjuvant therapy consisted
- •of fluoropyrimidine monotherapy. Subjects who received fluoropyrimidine alone must have received a second course of chemotherapy with fluoropyrimidine and either oxaliplatin or irinotecan or both, which should not exceed 9 months. For subjects with initial Stage I or II disease, no chemotherapy is required for a primary CRC lesion treated with surgery with curative intent. These subjects must receive chemotherapy for the treatment of
- •liver metastases (which were also treated with surgery with curative intent), which must last at least 3 months, including a fluoropyrimidine and either oxaliplatin or irinotecan or both. The total course of chemotherapy should not exceed 9 months.
- •Radiofrequency ablation and chemoembolization are not permitted. Subjects undergoing a planned 2-stage resection of liver metastases may be enrolled into the study.
- •5. Have tumor tissue (of primary tumor and liver metastases or at least one of the two) available for biomarker analysis (to be collected as soon as possible before or after randomization).
- •6. Prior to randomization, have histological confirmation that CRC lesions were adenocarcinoma (subtypes of adenocarcinoma, eg, mucinous adenocarcinoma, are allowed). Subjects with CRC lesions of other histologic types, including mixed type with predominant adenocarcinoma, will not be eligible to be randomized to study
- •7. Prior to randomization, have pa
排除标准
- •1.Are taking strong CYP3A4 inhibitors(eg,clarithromycin,indinavir,itraconazole,ketoconazole,nefazod one,nelfinavir,posaconazole,ritonavir,saquinavir,telithromycin,voriconazole)or strong CYP3A4 inducers (eg,carbamazepine,phenobarbital,phenytoin,rifampin,St. John's Wort).
- •2.Have used biologic response modifiers,such as granulocyte-colony stimulating factor,within 3 weeks prior to signing the ICF
- •3.Have had prior treatment with regorafenib or any other VEGFRtargeting kinase inhibitor.
- •4.Have had anti-cancer treatment following liver resection that exceeded a duration of 6 months.
- •5.Have been treated with biologics(eg,antibodies targeting VEGFR or EFGR)after liver resection unless the administration of the biologic started prior to liver resection and continued after liver resection only to complete a pre-specified number of cycles.
- •6.Completed their last dose of chemotherapy or had their last cancer surgery more than 10 weeks,whichever came later,prior to randomisation.
- •7.Have extra-hepatic metastatic disease.Suspicious lesions should be rigorously evaluated with other imaging techniques and/or biopsy to exclude extra-hepatic metastatic disease prior to submitting for central radiology review.
- •8.Have been previously assigned to treatment during this study(subjects permanently withdrawn from study treatment will not be allowed to reenter the study).
- •9.Have had prior or concurrent cancer distinct in primary site or histology from CRC within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ,nonmelanoma skin cancer.Stage 0 intramucosal gastric cancer after endoscopic complete removal,or superficial bladder tumors classified as noninvasive tumor(Ta),carcinoma in situ(Tis),or tumor invades lamina propria(T1).
- •10.Have had systemic anticancer therapy including cytotoxic therapy,signal transduction inhibitors,immunotherapy,and/or hormonal therapy within 4 weeks prior to initiation of study treatment.
- •11.Have unresolved toxicity higher than National Cancer Institute-
- •Common Terminology for Adverse Events version 4.0(NCI-CTCAE v 4.0)Grade 1 attributed to any prior therapy/procedure,excluding alopecia and/or oxaliplatin-induced neurotoxicity=Grade 2 and hemoglobin=9g/dL as per inclusion criteria.
- •12.Have had a major surgical procedure,open biopsy,or significant traumatic injury within 28 days prior to initiation of study treatment.
- •13.Are pregnant.
- •14.Are breastfeeding.
- •15.Are unable to swallow oral tablets(crushing of study treatment tablets is not allowed).
- •16.Have congestive heart failure classified as New York Heart Association Class 2 or higher.
- •17.Have had unstable angina(angina symptoms at rest)or new-onset angina =3months prior to screening.
- •18.Have had a myocardial infarction <6 months prior to initiation of study treatment.
- •19.Have cardiac arrhythmias requiring anti-arrhythmic therapy,with the exception of beta blockers or digoxin.
- •20.Have uncontrolled hypertension(systolic blood pressure >140 mmHg or diastolic blood pressure >90mmHg)despite optimal medical management.
- •21.Have pheochromocytoma.
- •22.Have had arterial or venou
研究者
相似试验
进行中（未招募）
1 期
Placebo-controlled Trial of Pembrolizumab in Esophageal Carcinoma Participants Receiving Concurrent dCRTEsophageal CarcinomaMedDRA version: 21.0Level: LLTClassification code 10015366Term: Esophageal carcinomaSystem Organ Class: 100000004864EUCTR2019-002006-51-DKMerck Sharp & Dohme LLC600
进行中（未招募）
1 期
A Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy in Participants with Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)imited-Stage Small Cell Lung Cancer (LS-SCLC)MedDRA version: 21.1Level: LLTClassification code 10041071Term: Small cell lung cancer stage unspecifiedSystem Organ Class: 100000004864EUCTR2019-003616-31-PTMerck Sharp & Dohme LLC672
进行中（未招募）
不适用
A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients with Previously Treated Indolent Non-Hodgkin LymphomaIndolent Non-Hodgkin Lymphoma (iNHL)MedDRA version: 14.1Level: HLTClassification code 10029621Term: Non-Hodgkin's lymphomas unspecified histology indolentSystem Organ Class: 100000004851EUCTR2013-003093-27-ESJanssen-Cilag International NV400
进行中（未招募）
不适用
Brodalumab in Subjects with Psoriatic ArthritisPsoriatic ArthritisEUCTR2013-003554-25-GBAmgen Inc.630
进行中（未招募）
1 期
A Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic CancerPatients with metastatic adenocarcinoma of the pancreas who have not received prior therapy for their metastatic diseaseMedDRA version: 20.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864EUCTR2014-004572-34-DEMerrimack Pharmaceuticals, Inc.91