EUCTR2013-004552-38-GB进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients (males and females) age = 18 years
- •- Histologically confirmed diagnosis of unresectable stage III or metastatic melanoma (stage IIIC to IV per American Joint Committee on Cancer [AJCC])
- •- Documented evidence of BRAF V600 mutation.
- •- Evidence of measurable disease, as determined by RECIST v1.1.
- •Inclusion criteria for triple combinations:
- •- Progressive disease following prior treatment with LGX818/MEK162 combination.
- •- A pre-LGX818/MEK162 combination archival tumor sample must be available
- •Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •Patients eligible for Part I or Run-in of this study must NOT meet any of the following criteria:
- •1. Symptomatic or untreated leptomeningeal disease.
- •2. Symptomatic brain metastasis.
- •3. Patients are not permitted to receive enzyme inducing anti-epileptic drugs.
- •4. Known acute or chronic pancreatitis.
- •5. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
- •6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs (e.g., ulcerative
- •diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
- •7. Patients treated with warfarin or other coumadin derived anti coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
- •8. Previous or concurrent malignancy. Exceptions: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to first dose administration.
- •9. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study UNLESS they are using highly effective methods of contraception throughout the study and for 3 months after study drug discontinuation.
- •10. Sexually active males must use a condom during intercourse while taking the drug and for 3 months after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
- •Enrollment in Part II
- •As of Protocol Amendment 06, enrollment to the BKM120-, BGJ398- and
- •INC280-containing arms in Part II is closed. Therefore, in Part II, patients who are eligible may only enroll in the LGX818/MEK162 + LEE011 arm.
- •11. 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.
- •- LGX818/MEK162 + INC280: This arm is closed to enrollment as this combination is no longer being explored (Amendment 06).
- •12. Patients unable to stop known CYP3A4, CYP1A2, CYP2C8 or CYP2C19 substrates with narrow therapeutic index. These medications should be stopped 7 days prior to first dose of study treatment (refer to Section 6.4.3 and
- •Appendix 7 for prohibited medications for this combination treatment).
- •13. Patients receiving treatment with long acting proton pump inhibitors, and unable to discontinue them 3 days prior to the start of study
- •treatment and during the course of the study.
- •14. Asymptomatic serum amylase > CTCAE Grade 2 (1.5-2.0xULN). Patients with Grade 1 or Grade 2 serum amylase at the beginning of the
- •study must be confirmed to have no signs or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal imaging findings of pancreas, etc.)
- •- LGX818/MEK162 + BGJ398: This arm is closed to enrollment as this combination is no longer being explored (Amendment 06)
- •15. History and/or
研究者
相似试验
进行中（未招募）
1 期
GX818/MEK162 Combination With Agents (BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanomaocally Advanced or Metastatic BRAF V600 MelanomaEUCTR2013-004552-38-ESArray Biopharma Inc.35
进行中（未招募）
1 期
GX818/MEK162 Combination With Agents (BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanomaocally Advanced or Metastatic BRAF V600 MelanomaEUCTR2013-004552-38-NLArray BioPharma Inc.120
进行中（未招募）
1 期
GX818/MEK162 Combination With Agents (BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanomaocally Advanced or Metastatic BRAF V600 MelanomaMedDRA version: 17.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864EUCTR2013-004552-38-ITOVARTIS FARMA S.p.A.140
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 melanomaskin cancer10040900melanomaNL-OMON45032Array Biopharma15
进行中（未招募）
不适用
A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Ageno medical, conditionhealthy, at risk volunteers will be recruited for a clinical trial to receive three vaccinations against meningococcal strain B and one vaccination against meningococcal strains A,C, W and Y.EUCTR2007-001563-29-DEovartis Vaccines and Diagnostics S.r.l.250