NOVARTIS CAUY922A2101: A PHASE I DOSE ESCALATION, MULTI-CENTER, OPEN-LABEL STUDY

诺华 CAUY922A2101：I 期剂量递增、多中心、开放标签研究

• 批准号: 8167108
• 负责人: CAROLYN D BRITTEN
• 金额: $ 0.07万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167108
• 关键词: Adjuvant; Adult; Cancer Patient; Computer Retrieval of Information on Scientific Projects Database; Disease; Disease Progression; Dose; ERBB2 gene; Funding; Grant; Institution; Neoplasm Metastasis; Patients; Phase; Recording of previous events; Regimen; Research; Research Personnel; Resistance; Resources; Schedule; Solid Neoplasm; Source; Staging; Systemic disease; Trastuzumab; United States National Institutes of Health; advanced disease; arm; base; design; hormone therapy; malignant breast neoplasm; open label; patient population; response

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. SPECIFIC AIMS: Primary objective - dose escalation arm " To determine the MTD of AUY922 as a single agent when administered IV on a once weekly schedule to adult patients with advanced solid tumors, whose disease has progressed despite standard therapy or for whom no standard therapy exists. Primary objective - breast cancer dose expansion arm " At the MTD two further arms will be expanded to assess response (according to a two stage multinomial design) in the following breast cancer patient populations: 1. Patients with HER2 positive non-operable locally advanced or metastatic breast cancer must have: 1. History of trastuzumab resistance, defined as either local or systemic disease progression on treatment with at least 8 weeks of a trastuzumab containing regimen. 2. Received at least 1 but no more than 2 prior anti HER2 based regimens including at least 1 regimen containing trastuzumab. (Patients who develop metastases while receiving adjuvant or neo-adjuvant trastuzumab are eligible) 2. Patients with ER positive non-operable locally advanced or metastatic breast cancer who received standard sequence lines of endocrine therapy and whose disease has progressed on at least one line of endocrine therapy for advanced disease.

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。 具体目标： 主要目的-剂量递增组 “确定AUY 922作为单一药物每周一次静脉给药时的MTD，用于晚期实体瘤成人患者，尽管接受标准治疗或没有标准治疗，但疾病仍在进展。 主要目的-乳腺癌剂量扩展组 “在MTD时，将进一步扩大两组，以评估以下乳腺癌患者人群的反应（根据两阶段多项式设计）： 1. HER 2阳性不可手术的局部晚期或转移性乳腺癌患者必须： 1. 曲妥珠单抗耐药史，定义为接受至少8周含曲妥珠单抗方案治疗后局部或全身疾病进展。 2. 既往接受过至少1种但不超过2种基于抗HER 2的方案，包括至少1种含曲妥珠单抗的方案。（在接受辅助或新辅助曲妥珠单抗治疗期间发生转移的患者符合资格） 2. 接受标准序贯线内分泌治疗的ER阳性不可手术局部晚期或转移性乳腺癌患者，并且在接受至少一线内分泌治疗晚期疾病时疾病进展。