NL-OMON52799已完成不适用
A Phase Ib, multicenter, open-label dose escalation and expansion platform study of select druk combinations in adult patients with advanced or metastatic BRAF V600 colorectal cancer. - CADPT01C12101 (CRC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 21
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
- •Patients must be >= 18 years of age.
- •ECOG performance status <= 1.
- •Patients must have a site of disease amenable to biopsy, and be a candidate for
- •tumor biopsy according to the treating institution*s guidelines.
- •All patients must have a BRAF V600 mutation confirmed by local assessment.
- •Patients with unresectable advanced/metastatic BRAF V600 cancer of the colon or
- •rectum with measurable disease as determined by RECIST v1.1
- •See for more details protocol section 5.1
排除标准
- •Impairment of gastrointestinal function or gastrointestinal disease that may
- •significantly alter the absorption of study drugs
- •Patients with CNS tumor involvement, unless > 2 weeks after completion of
- •CNS-therapy, stable with respect to CNS-involvement, not receiving steroids or
- •on stable dose of < 10 mg/day for two weeks.
- •Out of range laboratory values:
- •Hemoglobin (Hgb) < 9.0 g/dL
- •Platelets < 75 x 109/L
- •Serum total bilirubin > 1.5 x upper limit of normal (ULN),
- •Asparate aminotransferase (AST) > 3 x ULN
- •Alanine aminotransferase (ALT) > 3 x ULN
- •Serum creatinine > 1.5 x ULN OR Creatinine Clearance < 60 mL/min
- •Other exclusion criteria may apply, please see protocol section 5.2
研究者
相似试验
已完成
不适用
A Phase Ib, multicenter, open-label dose escalation and expansion platform study of select immunotherapy combinations in adult patients with triple negative breast cancerNL-OMON49712ovartis4
招募中
1 期
Study of safety and preliminary efficacy of VAY736 given alone or in combination with other antineoplastic agents in patients with NHon-Hodgiking LymphomaJPRN-jRCT2031210238Suzuki Kazuyuki86
进行中（未招募）
1 期
Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)EUCTR2019-002666-12-DEovartis Pharma AG128
进行中（未招募）
1 期
Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)EUCTR2019-002666-12-FIovartis Pharma AG128
尚未招募
不适用
A Phase Ib Multicenter, Open-label Dose-escalation Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Durvalumab in Combination with Cisplatin, Carboplatin or Pemetrexed in First-line Treatment of Patients with Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 Overexpression (HER2+) (DESTINY-Lung03) (D967YC00001)NL-OMON50973Astra Zeneca4