CLINICAL TRIAL: ON 01910NA 3 DAY CONTINUOUS INFUSION IN PATIENTS WITH ADVANCED C

临床试验：01910NA 对晚期 C 患者连续输注 3 天

• 批准号: 7718143
• 负责人: TAKAO OHNUMA
• 金额: $ 63.41万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-03-01 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718143
• 关键词: Advanced Malignant Neoplasm; Adverse effects; Adverse event; Animal Model; Antineoplastic Agents; Cancer Patient; Cell Line; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Consent; Continuous Infusion; Diagnosis; Diarrhea; Disease Progression; Dose; Drug resistance; Exclusion Criteria; Funding; Grant; Hour; Infusion procedures; Institution; Investigation; Knowledge; Label; National Cancer Institute; Other Therapy; Patients; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Protocols documentation; Recovery; Research; Research Personnel; Resources; Sales; Schedule; Source; Therapeutic Index; Treatment Protocols; Tumor Cell Line; United States Food and Drug Administration; United States National Institutes of Health; Universities; Week; Withdrawal; cohort; day; interest; oncology; research study

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hypothesis: The antitumor effects of ON 01910.Na on a broad spectrum of tumor cell lines in culture and animal models, including many drug resistant cell lines, and its high therapeutic index, provide a strong rationale for clinical studies in the treatment of cancer patients. This study is for patients who have a diagnosis of an advanced cancer, which cannot be cured with present knowledge and for which no other therapy is known to be consistently effective. This research study will use ON01910.Na, a new anticancer agent, which is investigational (has been approved by the Food and Drug Administration for study but not for sale). This is an open-label, dose-escalating Phase I study of ON 01910.Na in ambulatory patients with advanced cancers, who have satisfied the inclusion/exclusion criteria enumerated in this protocol. Patients will receive ON 01910.Na intravenously by 3-day continuous infusion every 2 weeks, until evidence of disease progression, specific adverse events quantified by an established scale of the National Cancer Institute to reach a level of grade 3 (out of 4) in two patients in a cohort of 4 to 6 patients, or withdrawal of patient consent. After the Recommended Phase II Dose has been determined, up to an additional 12 patients may be added to confirm the appropriateness of the Recommended Phase II Dose. This regimen of a 3-day continuous infusion every 2 weeks, is an interesting and appropriate alternative dose regimen to the 2-hour, twice a week infusion schedule for 3 weeks with 10 days recovery, that is currently under investigation under a different protocol (04-01) at The Johns Hopkins University Oncology Center. Five patients have been studied for up to six doses. The only toxic side effect that has occurred was grade 1 diarrhea in one patient (possibly drug related).

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 假设：ON 01910.Na对培养物和动物模型中的广谱肿瘤细胞系（包括许多耐药细胞系）的抗肿瘤作用及其高治疗指数为癌症患者治疗的临床研究提供了强有力的依据。这项研究是针对诊断为晚期癌症的患者，这些癌症无法用现有的知识治愈，并且没有其他已知的治疗方法可以持续有效。本研究将使用ON01910.Na，这是一种新的抗癌药物，属于试验性药物（已获得美国食品药品监督管理局批准用于研究，但未销售）。 这是一项在符合本方案中列举的入选/排除标准的非卧床晚期癌症患者中开展的ON 01910.Na开放标签、剂量递增I期研究。 患者将接受ON 01910.Na静脉给药，每2周一次，连续输注3天，直至出现疾病进展的证据，在4 - 6例患者的队列中，有2例患者发生由国家癌症研究所确定的量表量化的特定不良事件达到3级（共4级），或撤回患者知情同意。 在确定推荐的II期剂量后，最多可增加12例患者，以确认推荐的II期剂量的适当性。 这种每2周一次连续输注3天的方案是一种有趣且适当的替代剂量方案，可替代2小时、每周两次输注方案，持续3周，恢复期10天，目前正在约翰霍普金斯大学肿瘤中心根据不同方案（04-01）进行研究。 已经对五名患者进行了多达六次剂量的研究。 唯一发生的毒副作用是1例患者发生的1级腹泻（可能与药物相关）。