NL-OMON47396已完成不适用
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 - Ribociclib (LEE011) and trametinib (TMT212) in solid tumors
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
- 12
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.Patient has histologically and/or cytologically confirmed malignancies:
- •Phase I: advanced or metastatic solid tumors who have failed at least one prior line of systemic antineoplastic therapy without a standard of care treatment option available.
- •Phase II: Advanced or metastatic pancreatic adenocarcinoma who have failed at least one prior systemic antineoplastic therapies and advanced or metastatic KRAS-mutant CRC who have failed at least two prior systemic antineoplastic therapies without a standard of care treatment option available.
- •2. Phase II only: measurable disease.
- •3. ECOG performance status 0 or 1.
- •4. Adequate bone marrow and organ function (see protocol 5.2 inclusion criterium 7)
- •5. 12-lead ECG values (mean of triplicate ECGs): QTcF interval at screening <450 msec (using Fridericia*s correction) and resting heart rate 50-90 bpm
- •For details see protocol section 4.2 pages 46-47
排除标准
- •1. Phase II only:Patient has received prior treatment with a MEK inhibitor or a CDK4/6 inhibitor.
- •Phase Ib and Phase II:
- •2. Radiotherapy * 4 weeks or limited field radiation for palliation * 2 weeks prior to Cycle 1 Day 1, and who has not recovered to grade 1 (with the exception of alopecia).
- •3. Local therapy to liver * 3 months of C1D1, Local therapy includes surgical resection, radiotherapy, and/or embolization/ablation.
- •4. History of liver disease as follow: Cirrhosis - Autoimmune hepatitis - Active viral hepatitis - Portal hypertension - Drug induced liver steatosis
- •5. Prior systemic anti-cancer treatment within 28 days prior to Cycle 1 Day 1, or chemotherapy without delayed toxicity within the last 2 weeks preceding the first dose of study treatment with no more than grade 1 treatment related AEs..
- •6. Warfarin or other Coumadin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
- •7. History of deep vein thrombosis or pulmonary embolism within 6 months from screening.
- •8. CNS involvement unless they meet ALL of the criteria specified in protocol bullet 12.
- •9. Impairment of GI function or GI disease that may significantly alter the absorption of the study drugs
- •10. A known history of HIV infection
- •11. History of interstitial lung disease or pneumonitis.
- •12. Any other concurrent severe or uncontrolled medical condition
- •13. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality. See details in protocol bullet 17.
- •14. Currently receiving any of the substances listed in protocol bullet 19 and cannot be discontinued 7 days prior to the start of the study medication.
- •15. 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.
- •16. History of retinal vein occlusion.
- •For detailed description of exclusion criteria see protocol section 4.3 pages 65-68
研究者
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