NL-OMON50511招募中2 期
Phase II, Open-label, Study in Subjects with BRAF V600E - Mutated Rare Cancers with Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib (BRF117019) - BRF117019
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 15
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 99（—）
入选标准
- •Males and females, 18 years and above.
- •BRAF mutation positive tumor.
- •ECOG Performance Status 0-2.
- •Advanced disease, no standard treatment options.
- •ATC, BTC, GIST, NSGCT/NGGCT, ASI: at least 1 measurable lesion.
- •Females of childbearing potential: adequate method of contraception.,
- •Histology-specific criteria, see protocol:
- •Anaplastic Thyroid Cancer: page 61.
- •Biliary Tract Cancer: page 61.
- •Gastrointestinal Stromal Tumors: page 61.
- •WHO Grade 1 and 2 Glioma: page 61.
- •WHO Grade 3 and 4 Glioma: page 62.
- •Germ Cell Tumors: page 62.
- •Adenocarcinoma of the Small Intestine: page 63.
- •Hairy Cell Leukemia: page 63.
- •Multiple Myeloma: page 64.
排除标准
- •Prior treatment with BRAF and/or MEK inhibitor.
- •Anti-cancer therapy within 21 days (or within 42 days if prior nitrosourea or
- •mitomycin C containing therapy) prior to enrollment and/or daily or weekly
- •chemotherapy without the potential for delayed toxicity within 14 days prior to
- •enrollment.
- •Chemotherapy or biologic therapy within 14 days prior to enrolment without
- •evidence of delayed toxicity.
- •Investigational drug(s) within 30 days or 5 half-lives, whichever is longer,
- •prior to enrollment.
- •Prior radiotherapy treatment and/or major surgery less than 14 days prior to
- •enrolment. Exceptions: see protocol page 51.
- •History of interstitial lung disease or pneumonitis.
- •Neurological involvement, see protocol page 52-53 for details.
- •A history of retinal vein occlusion.
- •A history or evidence of cardiovascular risk, see protocol page 53-54 for
- •Pregnancy or breastfeeding, Histology-specific criteria, see protocol:
- •Anaplastic Thyroid Cancer: page 67.
- •Biliary Tract Cancer: page 67.
- •WHO Grade 1 and 2 Glioma: page 67.
- •WHO Grade 3 and 4 Glioma: page 67.
研究者
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