EUCTR2009-014876-23-NL进行中（未招募）不适用
A Phase 2 Study of EZN-2208 (PEG-SN38) Administered With or Without Cetuximab in Patients with Metastatic Colorectal Carcinoma (mCRC)
Enzon Pharmaceuticals, Inc0 个研究点目标入组 220 人开始时间: 2009年12月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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
- •Inclusion Criteria:
- •Patients must meet all of the following criteria to be eligible for enrollment in the study.
- •1. Capable of understanding the protocol requirements and risks and providing written informed consent
- •2. Histologically confirmed CRC adenocarcinoma that is metastatic or locally recurrent CRC that is nonresectable
- •3. Patients must agree to genetic testing of the original or metastatic CRC tumor biopsy tissue for K-RAS
- •mutational status. Participation in study requires the availability of the tumor biopsy and written patient consent
- •for K-RAS genotyping of the tumor tissue. Lack of tumor tissue or patient refusal to allow genotyping makes the patient ineligible for the study.
- •Note: If a patient’s K-RAS mutational status was tested using the DxS assay before enrolling in this trial, the
- •patient’s K-RAS mutational test will not be duplicated if it was performed using a validated assay at a certified
- •laboratory. If a patient’s K-RAS mutational status was tested before enrolling in this trial using
- •other assays that evaluate mutations in codons 12 or 13, the patient may enroll in the study on the basis of these
- •results; however, the patient’s K-RAS mutational test will be duplicated using a validated assay at a certified
- •laboratory. Patients will need to consent to repeat testing of tumor genotype. Lack of tumor tissue or patient
- •refusal to allow genotyping makes the patient ineligible for the study.
- •4. Disease progression
- •5. Previous therapy with irinotecan, oxaliplatin, and fluoropyrimidine either alone or in any combination(s).
- •Patients must have radiographically documented progressive disease while receiving, or within 3 months of
- •receiving, these agents alone or in combination.
- •6. No more than 2 prior cytotoxic chemotherapy regimens. Biologic agents and targeted non-cytotoxic therapies
- •do not count with respect to the number of prior regimens .
- •7. Age 18 years or older
- •8. Measurable disease by RECIST Version 1.1 is required: NLT 1 tumor with NLT 10 mm (assuming computed
- •tomography slice thickness of 5 mm minimum). If the CT slice thickness is >5 mm, the measurable lesion
- •minimum is 2× slice thickness. Measurable disease is defined as at least one lesion for which the longest
- •diameter can be accurately measured. The only evidence of metastasis must not be nonmeasurable disease such
- •as leptomeningeal disease, ascites, pleural or pericardial effusion, inflammatory breast disease, lymphangitic
- •involvement of skin or lung, or abdominal masses/abdominal organomegaly identified by physical examination
- •that is not measureable by reproducible imaging techniques.
- •9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate bone marrow, renal, and hepatic function
- •Hemoglobin NLT 9.0 g/dL (no history of blood transfusion in the prior 2 weeks)
- •Absolute neutrophil count (ANC) NLT 1,000/microlitre
- •Platelet count NLT 75,000/microlitre
- •Serum creatinine NMT 1.5 times the upper limit of normal (ULN)
- •Total bilirubin within normal limits
- •Transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [(ALT]) NMT 2.5 times the
- •ULN (may be NMT 5 times the ULN if the increase is due to metastatic disease to the liver)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any of the following exclusion criteria will not be eligible for enrollment.
- •1. Concurrent serious medical illness that could potentially interfere with protocol compliance
- •2. Previous cancer treatment with cetuximab (Erbitux), panitumumab (Vectibix), or any other anti-EGFR
- •therapies. Patients previously treated with such therapy who are found to have mutated K-RAS tumors and who
- •meet all other eligibility criteria are eligible for participation in Arm A of the study.
- •3. Positive screening pregnancy test or is breast-feeding
- •4. Female or male patient of reproductive capacity unwilling to use methods appropriate to prevent pregnancy
- •during this study
- •5. Known chronic infectious disease, such as acquired immunodeficiency syndrome (AIDS)
- •6. Major surgery within 3 weeks before study start
- •7. Known or suspected brain metastases requiring intervention with steroids and/or radiation therapy. Patients
- •with previously treated brain metastases who are currently asymptomatic and not requiring steroids are eligible.
- •8. Prior chemotherapy, immunotherapy, non-investigational agent, or other therapy used to treat the cancer within 3 weeks (6 weeks for prior treatment with mitomycin C) before the scheduled administration of EZN-2208
- •9. History of other primary cancer within 5 years of enrollment, unless
- •a. Curatively resected non-melanomatous skin cancer, or
- •b. Curatively resected cervical cancer
- •10. Lack of recovery to Grade 1 from any reversible side effects (except alopecia or Grade 2 sensory neuropathy) related to the administration of an investigational agent, chemotherapy, immunotherapy, surgery, radiotherapy, or other treatments for the cancer
- •11. Any condition such as uncontrollable diabetes, uncontrollable hypertension, or active infection that, in the
- •opinion of the principal investigator (PI) or Enzon, makes the patient unsuitable for the study. The PI must
- •consider the potential side effects of SN38 therapy when evaluating a prospective study patient previously
- •treated with irinotecan.
- •12. Current participation in another clinical study with an investigational agent and/or use of an investigational
- •drug (not including investigational use of an approved drug) in the 30 days before the first administration of
- •13. Inability to comply with the study protocol
研究者
相似试验
进行中（未招募）
1 期
A Phase 2 Study of EZN-2208 (PEG-SN38) administered with or without Cetuximab in patients with Metastatic Colorectal Carcinoma (mCRC)Metastatic Colorectal Carcinoma (mCRC)MedDRA version: 13.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-014876-23-GBEnzon Pharmaceuticals, Inc.220
已完成
2 期
A phase 2 study of EZN-2208 (PEG-SN38) administered with or without cetuximab in patients with metastatic colorectal carcinoma (mCRC)colorectal cancercolorectal carcinoma10017990NL-OMON34687Enzon Pharmaceuticals, Inc.20
已完成
2 期
Exploratory Study of ZG-801 for the Treatment of HyperkalemiaHyperkalemiaJPRN-jRCT2080224547Zeria Pharmaceutical Co., Ltd.180
尚未招募
2 期
To study the effect of eladi ointmentCTRI/2020/09/028022Ayurved Mahavidyalaya Nashik
进行中（未招募）
1 期
A proof-of-concept, dose finding, controlled, single-senter, randomized, cross-over, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel SyndromeEUCTR2015-002826-38-DKZealand Pharma A/S