一、题目和背景信息
| 登记号 |
CTR20260204 |
| 相关登记号 |
暂无
|
| 药物名称 |
NA |
| 药物类型 |
化学药物
|
|
临床申请受理号
|
企业选择不公示 |
| 适应症 |
晚期实体瘤 |
| 试验专业题目 |
一项在BRAF 突变型黑色素瘤和其他实体瘤研究参与者中评估PF-07799544 单药治疗和与其他靶向药物联合治疗的Ia/b 期开放性主研究 |
| 试验通俗题目 |
一项在BRAF 突变型黑色素瘤和其他实体瘤研究参与者中评估PF-07799544 单药治疗或联合治疗的I 期研究 |
| 试验方案编号 |
C4901001 |
方案最新版本号
|
最终方案修正案5 |
| 版本日期: |
2025-07-07 |
方案是否为联合用药 |
是 |
二、申请人信息
| 申请人名称 |
[["Pfizer Inc."],["辉瑞（中国）研究开发有限公司"],["Pfizer Inc.；Patheon Inc., part of Pharma Services Thermo Fisher Scientific"]] |
| 联系人姓名 |
邱杰尔 |
联系人座机 |
021-28935395 |
联系人手机号 |
13120751538 |
| 联系人Email |
Jieer.Qiu@pfizer.com |
联系人邮政地址 |
上海市-上海市-南京西路1168号中信泰富广场36层 |
联系人邮编 |
200041 |
三、临床试验信息
1、试验目的
评估PF-07799544单药和与其他靶向药物联合治疗的安全性、耐受性、药代动力学、药效学和初步临床活性。
2、试验设计
| 试验分类 |
安全性和有效性 |
试验分期 |
I期
|
设计类型 |
单臂试验
|
| 随机化 |
非随机化
|
盲法 |
开放
|
试验范围 |
国际多中心试验
|
3、受试者信息
| 年龄 |
16岁(最小年龄)至
无上限
(最大年龄) |
| 性别 |
男+女
|
| 健康受试者 |
无
|
| 入选标准 |
[["诊断为晚期/转移性实体瘤（除外结直肠癌）"],["具有符合 RECIST 1.1 版定义的可测量病灶"],["存在BRAF V600突变"],["既往治疗符合各肿瘤队列要求"],["器官功能良好符合方案要求"],["年龄≥16岁，性别不限"]]
|
| 排除标准 |
[["3 年内患有其他活动性恶性肿瘤"],["存在软脑膜疾病"],["病史或当前证据表明存在 视网膜静脉闭塞（RVO ）或当前存在风险因素；存在视网膜变性史"],["并发与肌酸激酶（CK ）升高相关的神经肌肉疾病"],["存在符合方案定义的活动性胃肠道疾病"],["存在符合方案定义的间质性肺疾病病史"]]
|
4、试验分组
| 试验药 |
| 序号 |
名称 |
用法 |
[["中文通用名:NA
英文通用名:PF-07799544
商品名称:NA","剂型:片剂
规格:1mg
用法用量:PF-07799544:Bmg，每天两次，口服
用药时程:21天为一个疗程，研究干预给药将持续至出现疾病进展、因AE而停药、撤回知情同意、妊娠、研究者决定让研究参与者退出、研究参与者主动决定退出（非AE）、申办方终止研究、其他原因（非AE）或研究结束。"],["中文通用名:NA
英文通用名:PF-07799544
商品名称:NA","剂型:片剂
规格:2.5mg
用法用量:PF-07799544:Bmg，每天两次，口服
用药时程:21天为一个疗程，研究干预给药将持续至出现疾病进展、因AE而停药、撤回知情同意、妊娠、研究者决定让研究参与者退出、研究参与者主动决定退出（非AE）、申办方终止研究、其他原因（非AE）或研究结束。"],["中文通用名:NA
英文通用名:PF-07799544
商品名称:NA","剂型:片剂
规格:5mg
用法用量:PF-07799544:Bmg，每天两次，口服
用药时程:21天为一个疗程，研究干预给药将持续至出现疾病进展、因AE而停药、撤回知情同意、妊娠、研究者决定让研究参与者退出、研究参与者主动决定退出（非AE）、申办方终止研究、其他原因（非AE）或研究结束。"],["中文通用名:NA
英文通用名:PF-07799933
商品名称:NA","剂型:片剂
规格:25mg
用法用量:PF-07799933:Amg，每天两次，口服
用药时程:21天为一个疗程，研究干预给药将持续至出现疾病进展、因AE而停药、撤回知情同意、妊娠、研究者决定让研究参与者退出、研究参与者主动决定退出（非AE）、申办方终止研究、其他原因（非AE）或研究结束。"],["中文通用名:NA
英文通用名:PF-07799933
商品名称:NA","剂型:片剂
规格:100mg
用法用量:PF-07799933:Amg，每天两次，口服
用药时程:21天为一个疗程，研究干预给药将持续至出现疾病进展、因AE而停药、撤回知情同意、妊娠、研究者决定让研究参与者退出、研究参与者主动决定退出（非AE）、申办方终止研究、其他原因（非AE）或研究结束。"]]
|
| 对照药 |
|
5、终点指标
| 主要终点指标及评价时间 |
| 序号 |
指标 |
评价时间 |
终点指标选择 |
[["子研究D：根据 RECIST 1.1 版评估的 ORR（使用改良的 RECIST 1.1 版评估脑转移，使用 RANO 评估原发性脑肿瘤）","研究期间","有效性指标"],["两个中国队列： 单药或联合治疗的 PK 参数","研究期间","有效性指标+安全性指标"]]
|
| 次要终点指标及评价时间 |
| 序号 |
指标 |
评价时间 |
终点指标选择 |
[["按类型、频率、严重程度、时间、严重性及与研究治疗的关系描述的不良事件。n按类型、频率、严重程度和时间描述的实验室检查、体格检查和生命体征异常。","研究期间","安全性指标"],["子研究D：DOR、IC-ORR、IC-DOR、PFS，均根据 RECIST v 1.1进行评估（使用改良的 RECIST 1.1版评估脑转移[非原发性脑肿瘤]，使用 RANO评估原发性脑肿瘤）nOS","研究期间","有效性指标"],["中国队列：研究者根据 RECIST 1.1版评估的ORR（使用改良的 RECIST 1.1版评估脑转移）n根据 RECIST 1.1版评估的全身DOR（使用改良的 RECIST 1.1版评估脑转移）","研究期间","有效性指标"]]
|
四、研究者信息
1、主要研究者信息
| 1 |
姓名 |
范云 |
学位 |
医学博士 |
职称 |
主任医师 |
| 电话 |
13858182310 |
Email |
fanyun@zjcc.org.cn |
邮政地址 |
浙江省-杭州市-拱墅区半山东路1号 |
| 邮编 |
311000 |
单位名称 |
浙江省肿瘤医院 |
2、各参加机构信息
| 序号 |
机构名称 |
主要研究者 |
国家 |
省（州） |
城市 |
[["浙江省肿瘤医院","范云","中国","浙江省","杭州市"],["温州医科大学附属第一医院","谢聪颖","中国","浙江省","温州市"],["复旦大学附属华山医院","黄若凡","中国","上海市","上海市"],["福建省肿瘤医院（福建省肿瘤研究所、福建省癌症防治中心）","陈誉","中国","福建省","福州市"],["河南省肿瘤医院","罗素霞","中国","河南省","郑州市"],["湖南省肿瘤医院","蒲兴祥","中国","湖南省","长沙市"],["University of Texas7MD Anderson Cancer Center","JordiRodon Ahnert","USA","TX","Houston"],["Highlands Oncology Group","JosephBeck","USA","Arkansas","Springdale"],["Cleveland Clinic Taussig Cancer Center","DaleShepard","USA","Ohio","Cleveland"],["Fred Hutchinson Cancer Center","EvanHall","USA","Washington","Seattle"],["Henry Ford Hospital","AmyWeise","USA","Michigan","Detroit"],["Moffitt Cancer Center","Zeynep Eroglu","USA","FL","Tampa"],["CHU deQuebec -UniversiteLaval - HotelDieu？de Quebec","Olivier Dumas","Canada","Quebec","Quebec"],["Columbia University Irving Medical Center","AyaHaggiagi","USA","New York","New York"],["Jewish General Hospital","April Rose","Canada","Quebec","Montreal"],["Sunnybrook Research Institute","Rossanna Pezo","Canada","Ontario","Toronto"],["The Ottawa Hospital -General Campus","Arif Awan","Canada","Ontario","Ottawa"],["Princess Margaret Cancer Centre","XueyuChen","Canada","Ontario","Toronto"],["Cross Cancer Institute","Quincy Chu","Canada","Alberta","Edmonton"],["McGill University Health Centre","Ramy Saleh","Canada","Quebec","Montreal"],["Providence Portland Medical Center","Matthew Taylor","USA","Oregon","Portland"],["Hadassah Medical Center","Mordechai Avner","Israel","Yerushalayim","Jerusalem"],["SCRI Oncology Partners","Meredith McKean","USA","Tennessee","Nashville"],["SouraskyMedical Center","Ravit Geva","Israel","HaMerkaz","Tel Aviv, Yaffo"],["Rabin Medical Center","Nethanel Asher","Israel","HaMerkaz","Petah Tikva"],["Sheba Medical Center","Ronnie Shapira Frommer","Israel","HaMerkaz","Ramat Gan"],["Memorial Sloan Kettering Cancer Center","Monica Chen","USA","New York","New York"],["Soroka Medical Center","AlexanderYakobson","Israel","HaDarom","Be er Sheva"],["Dana-Farber Cancer Institute","Rizwan Haq","USA","Massachusetts","Boston"],["University of Wisconsin Carbone Cancer Center-University Hospital","Vincent Ma","USA","Wisconsin","Madison"],["USC/Norris Comprehensive Cancer Center","Gino In","USA","California","Los Angeles"],["HealthPartners Frauenshuh Cancer Center","Jayanthi Vijayakumar","USA","Minnesota","St. Louis Park"],["UPMC Hillman Cancer Center","Yana Najjar","USA","Pennsylvania","Pittsburgh"],["University of Pennsylvania","RaviAmaravadi","USA","Pennsylvania","Philadelphia"],["Northwestern University","SunandanaChandra","USA","Illinois","Evanston"],["The James Cancer Hospital and SoloveResearch Institute at The Ohio State University Comprehensive C","Merve Hasanov","USA","Ohio","Columbus"],["Ochsner Clinic Foundation","Daniel Johnson","USA","Louisiana","Kenner"],["Clinical Research Alliance","Jonathan Goldberg","USA","New York","Westbury"],["The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate","InderjitMehmi","USA","California","Los Angeles"],["Laura & Isaac Perlmutter Cancer Center at NYU Langone Health","Janice Mehnert","USA","New York","New York"],["Centro de Oncologia - CEON+ - Unidade Sao Caetano do Sul","Daniel Cubero","Brazil","Sao Paulo","Sao Caetano do Sul"],["Hospital Nossa Senhora da Conceiao","Gustavo Alves","Brazil","Rio Grande do Sul","PORTO ALEGRE"],["The University of Alabama at Birmingham","John Dubay","USA","Alabama","Birmingham"],["ANIMI - Unidade de TratamentoOncologico","MAITE SCHURMANN","Brazil","Santa Catarina","Lages"],["IBCC – Nucleo de Pesquisa e Ensino","Felipe Jose Cruz","Brazil","Sao Paulo","Sao Paulo"],["Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein","GustavoSchvartsman","Brazil","Sao Paulo","Sao Paulo"],["The Alfred Hospital","Andrew Haydon","Australia","VICTORIA","Melbourne"],["PeterMacCallumCancerCentre","Grant McArthur","Australia","VICTORIA","Melbourne"],["UCSF Helen Diller Medical Center at Parnassus Heights","Adil Daud","USA","California","San Francisco"],["National Cancer Center Hospital","Yoshitaka Honma","Japan","Tokyo","Chou-Ku"],["Kansai MedicalUniversity Hospital","Toshio Shimizu","Japan","Osaka","Hirakata"],["National Cancer Center Hospital East","Akira Takahashi","Japan","Chiba","Kashiwa"],["Massachusetts General Hospital","KamanehMontazeri","USA","Massachusetts","Boston"]]
五、伦理委员会信息
| 序号 |
名称 |
审查结论 |
批准日期/备案日期 |
[["浙江省肿瘤医院医学伦理委员会","同意","2025-11-11"]]
六、试验状态信息
1、试验状态
进行中（尚未招募）
2、试验人数
| 目标入组人数 |
国内: 18 ；
国际: 371 ； |
| 已入组人数 |
国内: 登记人暂未填写该信息；
国际: 115 ； |
| 实际入组总人数 |
国内: 登记人暂未填写该信息；
国际: 登记人暂未填写该信息； |
3、受试者招募及试验完成日期
| 第一例受试者签署知情同意书日期 |
国内：登记人暂未填写该信息；
国际：2022-11-30； |
| 第一例受试者入组日期 |
国内：登记人暂未填写该信息；
国际：2022-12-13； |
|
试验完成日期
|
国内：登记人暂未填写该信息；
国际：登记人暂未填写该信息； |
