NL-OMON42021已完成不适用
An open-label phase 1b study to evaluate the safety and efficacy of CCX872-B in patients with pancreatic adenocarcinoma. - Treatment of pt with pancreatic adenocarcinoma with CCX872-B.
Chemocentryx0 个研究点目标入组 29 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
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 64（—）
入选标准
- •1. Have histologically or cytologically confirmed pancreatic adenocarcinoma.;2. Eastern Cooperative Oncology Group (ECOG) performance status score <= 2.;3. Male or female subjects, aged at least 18 years; Female subjects of childbearing potential and male subjects with female partners of childbearing potential using adequate contraception. See also page 37 of the protocol.;4. Anticipated life expectancy >= 12 weeks.;5. Ability to provide written informed consent and comply with the requirements of the study protocol.;In part B of the study , subjects must additionally meet these entry criteria:;6. Have non-resectable pancreatic adenocarcinoma with or without metastases. ;7. Have radiographically measureable disease according to RECIST 1.1.
排除标准
- •1. Received other cancer treatment or any investigational drug within 4 weeks prior to screening.;2. Women who are pregnant or breastfeeding.;3. Had major surgery within 4 weeks of the first dose of study drug.;4. Inadequate liver, renal, or bone marrow function within 2 weeks before first dosing.;5. Serious concurrent illness, altered mental status or any uncontrolled medical condition.;6. Any infection requiring antibiotic or anti-viral treatment within 4 weeks of screening.;7. Known active HIV, HBV or HCV infection.;8. Taking agents known to be strong inhibitors or inducers of CYP3A4 or UGT1A1 within 2 weeks of Day 1 dosing; these include atazanavir, boceprevir, clarithromycin, conivaptan, gemfibrozil, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole, rifampin, and carbamazepine; use of these drugs must be avoided during the study and until 2 weeks after stopping CCX872-B treatment.;9. Taking any other test drug within 3 weeks or 5 half-lives (whichever is longer) prior to Day 1 of the study;;10. Inability to swallow tablets.;11. History or presence of any medical condition or disease which may place the subject at unacceptable risk for study participation.
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