CTIS2022-501465-40-00招募中1 期
Randomized Phase 2 Study of DKN-01 Plus FOLFIRI/FOLFOX and Bevacizumab Versus FOLFIRI/FOLFOX and Bevacizumab as Second-line Treatment of Advanced Colorectal Cancer (DeFianCe) - DEK-DKK1-P207
eap Therapeutics Inc.0 个研究点目标入组 156 人开始时间: 2022年10月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 156
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 65+（—）
- 性别
- All
入选标准
- •1. Histologically proven diagnosis of advanced colorectal adenocarcinoma (by local laboratory and local clinical guidelines) with documented objective radiographic or symptomatic disease progression following first-line systemic therapy with any fluoropyrimidine-based regimen for advanced disease (except FOLFOXIRI, see exclusion #3). • Patients may have received prior neoadjuvant or adjuvant therapy which could have included irinotecan or oxaliplatin. If progression has occurred within 12 months from last dose of neoadjuvant or adjuvant treatment, this regimen will be considered as the one line of systemic therapy for advanced disease. - If assigned to receive FOLFIRI, patient may have received no prior irinotecan as part of first-line systemic therapy. - If assigned to receive FOLFOX, patient may have received no prior oxaliplatin as part of first line systemic therapy. - Prior treatment with an anti-VEGF or anti-EGFR therapy is allowed as first-line and/or maintenance systemic therapy., Acceptable coagulation status: a. Prothrombin time/activated partial thromboplastin time =1.2 × ULN (unless receiving anticoagulation therapy, if receiving anticoagulation therapy, eligibility will be based upon international normalized ratio (INR), see (b) below. b. INR =1.5 (unless receiving anticoagulation therapy) If receiving anticoagulant: INR =3.0 and no active bleeding, (i.e., no clinically significant bleeding within 14 days prior to first dose of study drugs)., Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for at least 6 months after the last dose of study drugs and have a negative urine or serum pregnancy test within 7 days before first dose of study drugs, Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for at least 6 months after the last dose of study drugs. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. a. A sterile male is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility. b. Males with known low sperm counts” (consistent with sub-fertility”) are not to be considered sterile for purposes of this study, Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments, Age =18 years in North America or =19 years in the Republic of Korea on the day of signing the informed consent form, Presence of at least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1. (A lesion in an area subjected to prior loco-regional therapy, including previous radiotherapy, is not considered measurable unless there has been demonstrated progression in the lesion since the therapy as defined by RECIST v1.1.), Sufficient tumor tissue for mandatory pre-treatment evaluation (fresh biopsy [preferred], or archived tissue block specimen)., ECOG performance status =1 within 7 days of first dose of study drug, Acceptable liver function: a. Total bilirubin =1.5 times upper limit of normal (ULN) (if Gilbert’s disease present, then =3.0 times ULN is allowed). b. AST and ALT, =2.5 times ULN (if liver metastases are present, then =5 × ULN is allowed)., Acceptable renal function: a. Serum creatinine =1.5 × ULN or estimated glomerular filtration rate =3
排除标准
- •Microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) and/or BRAF V600E mutation positive colorectal cancer, Any of the following cardiovascular risk factors: a. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living within 28 days before first dose of study drug. b. Pulmonary embolism within 28 days before first dose of study drug. c. Any history of acute myocardial infarction within 6 months before first dose of study drug. d. Any history of heart failure meeting New York Heart Association Classification III or IV within 6 months before first dose of study drug. e. Any event of ventricular arrhythmia =Grade 2 in severity within 6 months before first dose of study drug. f. Any history of cerebrovascular accident, including transient ischemic attack, within 6 months before first dose of study drug. g. Clinically significant peripheral artery disease, Evidence of bleeding diathesis or significant coagulopathy, Prior therapy with an anti-DKK1 agent, Any episode of syncope or seizure within 28 days before first dose of study drug, Fridericia-corrected QT interval >470 msec (female) or >450 (male), or history of congenital long QT syndrome. Any ECG abnormality that in the opinion of the Investigator would preclude safe participation in the study; patients with pacemakers where QTc is not a reliable measure will require an evaluation by a cardiologist to exclude co-existing cardiac conditions which would prohibit safe participation in the study., Known to be human immunodeficiency virus (HIV) positive unless HIV RNA is undetected, have hepatitis B surface antigen, or hepatitis C antibodies unless hepatitis C virus ribonucleic acid (RNA) is undetected/negative, Serious nonmalignant disease or other circumstance that could compromise protocol objectives or place the patient at risk in the opinion of the Investigator and/or the Sponsor, History of osteonecrosis of the hip or have evidence of structural bone abnormalities in the proximal femur on magnetic resonance imaging (MRI) scan that are symptomatic and clinically significant. Degenerative changes of the hip joint are not exclusionary. Screening of asymptomatic patients is not required, Known osteoblastic bony metastasis. Screening of asymptomatic patients without a history of metastatic bony lesions is not required, Serious psychiatric or medical conditions that could interfere with treatment, Any active malignancy =2 years before first dose of study drug, with the exception of the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)., Toxicities (as a result of prior anticancer therapy) that have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities)., Administration of a live vaccine within 28 days before first dose of study drug. Note: Seasonal vaccines for influenza or COVID-19 vaccines are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed, Prior therapy with FOLFOXIRI, Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that will be unfavorable for the administration of study drug, or affect the explanation of drug toxicity or AEs,
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