NL-OMON43645已完成不适用
A phase Ib, open-label, multi-center, dose escalation and expansion study of an orally administered combination of BKM120 plus MEK162 in adult patients with selected advanced solid tumors - A phase Ib study with MEK162 in combination with BKM120
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
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 with the following histologically/cytologically confirmed, advanced solid tumor for whom no standard therapy exists:
- •Advanced pancreatic cancer (irrespective of KRAS or B-RAF mutation status).
- •Advanced colorectal with KRAS, NRAS or BRAF mutations.
- •Advanced melanoma with NRAS or BRAF mutations.
- •Advanced NSCLC with KRAS mutation.
- •Other advanced solid tumors with documented KRAS, NRAS or BRAF mutations.
- •Triple negative breast cancer.
- •Advanced NSCLC patients with EGFR activating mutations, who have progressed on a prior EGFR TKI based regimen and NSCLC patients known to have documented T790M activating mutations (expansion-arm only)
- •Measurable or non-measurable, but evaluable disease as determined by RECIST.
- •ECOG (WHO) performance status 0-2.
- •Adequate organ function and laboratory parameters:
- •Absolute Neutrophil Count >= 1.5 x 109/L
- •Hemoglobin >= 10 g/dl (=6.2 mmol/L)
- •Platelets >= 100 x 109/L
- •AST/SGOT and/or ALT/SGPT <= ULN (upper limit of normal) or <= 3.0 x ULN if liver metastases are present.
- •Serum bilirubin <= ULN (or <= 1.5 x ULN if liver metastases are present; or total bilirubin <= 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
- •Serum lipase <= ULN
- •Fasting glucose levels < 7.0 mmol/L (126 mg/dL) or 2-hrs glucose < 11.1 mmol/L (200 mg/L) during OGTT
- •Calculated or directly measured Creatinin Clearance * 50% LLN
- •Recovery from all adverse events of previous anti-cancer therapies, including surgery and radiotherapy, to baseline or to Grade <= 1, except for alopecia and < Grade 2 sensory peripheral neuropathy.
- •Adequate cardiac function
- •LVEF >= 50%
- •NYHA Class <= 2
- •QTc interval <= 480ms
排除标准
- •Patients with primary CNS tumor. Patients with clinically stable metastatic CNS tumors, not receiving steroid therapy and is not receiving anti-convulsive medications are eligible.
- •Prior systemic anti-cancer treatment:
- •cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment (e.g., 6 weeks for nitrosourea, mitomycin-C) prior to starting study treatment.
- •biologic therapy (e.g., antibodies) within a period of time which is <= 5 t1/2 or <= 4 weeks prior to starting study treatment.
- •continuous or intermittent small molecule therapeutics within a period of time which is <= 5 t1/2 or <= 4 weeks prior to starting study treatment.
- •any other investigational agents within a period of time that is less than the cycle length used for that treatment or <= 4 weeks prior to starting study treatment.
- •Prior radiotherapy to > 30% of bone marrow.
- •Major surgery <= 4 weeks prior to starting study treatment.
- •History of prior significant toxicity from another MEK- or PI3K pathway inhibitor requiring discontinuation of treatment.
- •Prior treatment with combinations of MEK and PI3K/mTOR/ AKT inhibitors.
- •Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- •History/evidence of acute coronary syndromes (including MI, unstable angina, CABG, coronary angioplasty, or stenting), < 6 months prior to screening.
- •Symptomatic heartfailure, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality, e.g. congential long QT syndrome, high-grade/complete AV-blockage.
- •Uncontrolled arterial hypertension defined by BP > 140/100 mmHg at rest.
- •Patients with diabetes mellitus.
- •Mood disorders as judged by the Investigator or a Psychiatrist, or meets the cut-off score of >= 10 in the PHQ-9 depression scale or a cut-off of >= 15 in the GAD-7 mood scale, respectively, or selects a positive response of *1, 2, 3* to question number 9 in the PHQ-9 depression scale (potential for suicidal thoughts) and any of the following:
- •Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)
- •>=CTCAE grade 3 anxiety
- •History or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or ophthalmopathy at baseline that would be considered a risk factor for CSR/RVO
- •Any other condition that would, in the investigator*s judgment, contraindicate patient*s participation in the clinical study due to safety concerns or compliance with clinical study procedures.
研究者
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