A double-blind, placebo-controlled, randomized, dose-escalating, multicenter, Phase 1 study to assess the safety and tolerability of ART-123 in combination with leucovorin/5-fluorouracil/oxaliplatin and bevacizumab in metastatic colorectal cancer patients
- Conditions
- metastatic colorectal cancer
- Registration Number
- JPRN-jRCT2051210165
- Lead Sponsor
- Tawara Shunsuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
*18 years of age or older
* Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
* ECOG performance status of 0 or 1
* The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges Willingness of the patient and the sexual partner to use a highly effective
contraceptive method during the course of the study
* Able to sufficiently understand the clinical study and give written informed consent
*History of major hemorrhage
* High risk of hemorrhage
* History of other malignancies
* Active ulcer
* Patients using anti-coagulants and fibrinolytic drugs
* Active Hepatitis B, or known HBs antigen positive
* Prior treatment history with thrombomodulin alfa
* Administration of another investigational medicinal product within 30 days prior to randomization
* Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period
* Patients otherwise deemed as inappropriate to participate in the study by the Investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety endpoints: AEs, Bleeding eventsDLTs, Laboratory tests, Vital signs (body temperature, systolic blood pressure, diastolic blood pressure, heart rate), Anti-ART-123 antibodies and neutralizing antibodies <br>PK endpoints: Plasma concentration of thrombomodulin, Plasma concentration of 5-FU, Plasma concentration of oxaliplatin, Serum concentration of bevacizumab
- Secondary Outcome Measures
Name Time Method