EUCTR2015-005019-34-NL进行中（未招募）1 期
A phase I/II study of safety and efficacy of ribociclib (LEE011) in combination with trametinib (TMT212) in patients with metastatic or advanced solid tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 153
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
- •Inclusion Criteria (All):
- •Written informed consent must be obtained prior to any study specific
- •screening procedures
- •Patient has histologically and/or cytologically confirmed malignancies:
- •Patients with advanced or metastatic solid tumors who have failed at
- •least one prior line of systemic antineoplastic therapy in the advanced
- •setting without a standard of care treatment option available;
- •Advanced or metastatic pancreatic adenocarcinoma who have failed at
- •least one prior systemic antineoplastic therapies in the advanced setting
- •Advanced or metastatic KRAS-mutant CRC who have failed at least two
- •prior systemic antineoplastic therapies in the advanced setting without a
- •standard of care treatment option available. Testing for KRAS mutation
- •in patients with CRC using locally approved diagnostic kit will be used for
- •eligibility.
- •Phase II only: patient must have measurable disease
- •Patient has an ECOG performance status 0 or 1.
- •Patient has adequate bone marrow and organ function
- •Patient must have specified laboratory values within normal limits or
- •corrected to within normal limits with supplements before the first dose
- •of study medication on Cycle 1 Day 1:
- •Standard 12-lead ECG values defined
- •Other protocol-defined inclusion/exclusion 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 91
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
排除标准
- •Phase II only:
- •Patient has received prior treatment with a MEK inhibitor or a CDK4/6
- •Phase I and Phase II:
- •Patient with a known hypersensitivity to the study drugs or any of the
- •excipients of ribociclib or trametinib.
- •Patient is concurrently using other anti-cancer therapy.
- •Patient has received radiotherapy = 4 weeks or limited field radiation
- •for palliation = 2 weeks prior to Cycle 1 Day 1
- •Patient has received local therapy to liver = 3 months of C1D1
- •History of liver disease as follow:
- •Autoimmune hepatitis
- •Portal hypertension
- •Drug induced liver steatosis
- •Prior systemic anti-cancer treatment within 28 days prior to Cycle 1
- •Prior therapy with anthracyclines at cumulative doses of 450 mg/ m2
- •or more for doxorubicin or 900 mg/m2 or more for epirubicin.
- •Patient is currently receiving warfarin or other coumadin derived anticoagulant
- •Patient has a history of deep venin thrombosis or pulmonary embolism
- •within 6 months of screening.
- •Patient has a concurrent malignancy or malignancy within 3 years prior
- •to Cycle 1 Day 1, with the exception of adequately treated basal or
- •squamous cell carcinoma or curatively resected cervical cancer.
- •Patients with central nervous system (CNS) involvement
- •Patient has impairment of GI function or GI disease that may
- •significantly alter the absorption of the study drugs
- •History of interstitial lung disease or pneumonitis.
- •Clinically significant, uncontrolled heart disease and/or cardiac
- •repolarization abnormality
- •Patient is currently receiving any strong inducers or inhibitors of
- •CYP3A4/5 and/or Substances that have a narrow therapeutic window
- •and are predominantly metabolized through CYP3A4/5 and cannot be
- •discontinued 7 days prior to Cycle 1 Day 1:
- •Patient is currently receiving or has received systemic corticosteroids =
- •2 weeks prior to starting study drug, or who have not fully recovered
- •from side effects of such treatment.
- •History of retinal vein occlusion (RVO)
- •Other protocol-defined inclusion/exclusion criteria may apply
研究者
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