NCT05868629招募中不适用
Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (1 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trametinib, irrespective of the trial participation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study participant with a BRAF V600E mutation-positive solid tumor as confirmed by a local laboratory test;
- •At least 1 measurable lesion as defined by RECIST v1.1 per local review;
- •Study participant previously not treated with dabrafenib and/or trametinib. Study participants who received dabrafenib and trametinib in the past for the treatment of other malignancies are eligible if treatment has been discontinued for greater than 1 year;
- •Ability to provide scans for central imaging review
排除标准
- •Those with the following tumor types: melanoma, NSCLC, ATC, BTC, glioma and CRC;
- •Study participants who have contraindication to receive dabrafenib and/ or trametinib according to the local label;
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Approximately 4 years
Proportion of study participants with a best overall confirmed Complete Response (CR) or Partial Response (PR) by independent central review according to RECIST v1.1 or other relevant response criteria.
次要结局
- Duration of response (DOR)(Approximately 4 years)
- Clinical benefit rate (CBR)(Approximately 4 years)
研究者
研究点 (7)
Loading locations...
相似试验
终止
4 期
Scale-up of Treatment of Hepatitis C Infection Among People Who Inject DrugsHepatitis CNCT02940691Kirby Institute32
已完成
4 期
Efficacy and Safety of Ikervis Under Controlled Environmental Conditions EnvironmentDry Eye SyndromesSevere KeratitisDry EyeNCT04492878Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA25
已完成
不适用
Correlation Study Between PEST and SCORAD in Management of Atopic Dermatitis With Ceradan® RegimenAtopic DermatitisNCT02073591Hyphens Pharma Pte Ltd58
已完成
4 期
Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).Metastatic Colorectal CancerNCT03564938Bayer100
已完成
2 期
Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric SubjectsWartsNCT00116675Graceway Pharmaceuticals, LLC84