NL-OMON45032已完成2 期
A phase II, multi-center, open-label study of sequential LGX818/MEK162 combination followed by a rational combination with targeted agents after progression, to overcome resistance in adult patients with locally advanced or metastatic BRAF V600 melanoma - LOGIC-2
Array Biopharma0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 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
- •1. Age >= 18 years at the start of dosing
- •2. Histologically confirmed diagnosis of unresectable stage III or metastatic melanoma (stage IIIC to IV per American Joint Committee on Cancer [AJCC]).
- •3. Documented evidence of BRAF V600 mutation
- •4. Evidence of measurable disease, as determined by RECIST v1.1.
- •5. ECOG Performance Status <= 2.
- •6. Negative serum pregnancy test within 72 hours prior to the first dose of study treatment in all women of childbearing potential.
- •7. For Group A only: patients who are naïve to selective BRAF and MEK inhibitors and might have received other allowed treatments
- •8. For Group A only: Patients must provide either archival or newly obtained tumor sample at baseline. In addition, patients must agree to a mandatory biopsy at the time of progression from LGX818/MEK162 combination, if not medically contraindicated.
- •9. For Group B only: Patients with progressive disease following any single or double-agent BRAF and MEK inhibitors other than LGX818/MEK162
- •10. For Group B only: The most recent biopsy sample collected after progression from any BRAF and/or MEK inhibitor (other than LGX818 and MEK162 combination) must be available before entering the Run-in. In addition, patients must agree to a biopsy at the time of progression from LGX818/MEK162 combination if necessary and not medically contraindicated.
- •11. For Group C only Progressive disease documented per RECIST v 1.1 and determined using radiological assessments, following prior treatment with LGX818/MEK162 combination.
- •12. For Group C only A pre-LGX818/MEK162 combination archival tumor sample must be available.
- •13. For Group C only A biopsy sample at disease progression, post-LGX818/MEK162 combination, must be either already available from previous studies or collectable at screening/baseline of this study..
- •14 Able to understand and voluntarily sign the informed consent form prior to any screening procedure, and ability to comply with the study visit schedule and other protocol requirements.
- •15. For Group B only: Patients who progressed after treatment with single agent BRAF or MEK inhibitor or the combination of BRAF/MEK inhibitors (excluding LGX818/MEK162 combination) and patients who did not progress on their prior BRAF and/or MEK inhibitor regimen (including LGX818 and/or MEK162 inhibitor), but did not tolerate this treatment, may enter the Run-in (Group B) upon consultation with Sponsor.
排除标准
- •Part I and Run-in
- •1. Symptomatic or untreated leptomeningeal disease.
- •2. Symptomatic brain metastasis.
- •3. Known acute or chronic pancreatitis.
- •4. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
- •5 Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery.;PART II
- •Patients are NOT eligible for enrollment in Part II of this study if they meet any exclusion criteria listed above, and all the applicable additional exclusion criteria listed below.
- •1. Patients who discontinued LGX818/MEK162 for more than 6 weeks prior to the scheduled first dose of triple combination (Part II), and AEs related to the above treatment are not resolved to at least grade 2.;Additional Exclusion Criteria for Part II for selected triple combination may apply. Please refer to the protocol.
研究者
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