NL-OMON39285尚未招募不适用
A phase I, multi-center, open-label, drug-drug interaction study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on TKI258 (dovitinib) pharmacokinetics in patients with advanced solid tumors. - A phase I drug-drug interaction study of fluvoxamin on TKI258 (dovitinib)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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. Patients diagnosed with either an advanced solid tumor, excluding breast cancer, or advanced hepatocellular carcinoma, which has progressed despite standard therapy, or for which no standard therapy exists
- •2. ECOG performance status <= 2
- •3. Absolute neutrophil count >= 1.5 x 109/L
- •4. Platelets >= 100 x 109/L
- •5. Hemoglobin >= 8.0 g/dL = 4.96 mmol/L
- •6. Serum creatinine <= 1.5 x ULN or 24-hour urine collection creatinine clearance >= 30 mL/min/1.73m2 (>= 50 mL/min/1.73m2 in the presence of proteinuria as defined in inclusion criterion #9) or,
- •Serum creatinine > 1.5 - 3 x ULN with calculated creatinine clearance >= 30 mL/min using the Cockcroft-Gault equation
- •7. Serum total bilirubin <= 1.5 x ULN
- •8. AST and ALT <= 3.0 x ULN
- •9. Urine dipstick negative for proteinuria or, if documentation of +1 results (+ 2 for patients with RCC) for protein on dipstick reading, then total urinary protein <= 500 mg and measured creatinine clearance >= 50 L/min/1.73m3 from a 24 hour urine collection
- •10. Patients with a life expectance of > 3 month
排除标准
- •1. Patients with brain metastases as assessed by mandatory radiologic imaging at screening
- •2. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
- •3. Prior anticancer therapies:
- •targeted small molecule therapy <= 2 weeks prior to starting study drug,
- •monoclonal antibody, immunotherapy, hormonal therapy, or chemotherapy <= 4 weeks prior to starting study drug,
- •nitrosourea or mitomycin-C <= 6 weeks prior to starting study drug
- •radiotherapy <= 4 weeks prior to starting the study drug (palliative radiotherapy for bone lesions <= 2 weeks prior to starting study drug is allowed)
- •and not recovered from anti-cancer therapy related toxicities
- •4. Major surgery <= 4 weeks prior to starting study treatment, or who have not recovered from side effects of such therapy
- •5. Pulmonary embolism or untreated deep venous thrombosis within 6 months prior to starting study drug
- •6. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- •History or presence of serious uncontrolled ventricular arrhythmias
- •Clinically significant resting bradycardia
- •LVEF < 50% (ECHO)or < 45% (MUGA)
- •Myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack within 6 months prior to starting study drug
- •Uncontrolled hypertension defined by a SBP >= 160 mm Hg and/or DBP >= 100 mm Hg, with or without anti-hypertensive medication(s). Initiation or adjustment of antihypertensive medication(s) is allowed prior to study entry
- •7. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib.
- •8. Cirrhosis, chronic active hepatitis, or chronic persistent hepatitis.
- •9. Current use of prasugrel, clopidogrel, or full dose anticoagulation treatment with therapeutic doses of warfarin. Treatment with low doses of warfarin (e.g., <= 2 mg/day) or locally accepted low doses of acetylsalicylic acid (up to 100 mg daily) is allowed.
- •10. Other concurrent severe and/or uncontrolled concomitant medical conditions
- •11. Use of potent and moderate CYP1A2 inhibitors or potent and moderate CYP3A inhibitors within 5 days prior to starting study treatment, or during the PK phase (i.e., days 1-28, inclusive, of the PK phase).
- •12. CYP1A2 inducers (including tobacco) or CYP3A inducers within 30 days prior to starting study treatment, or during the PK phase (i.e., days 1-28, inclusive, of the PK phase))
- •13. Actively taking antidepressants, benzodiazepines, serotonergic drugs, and/or monoamine oxidase inhibitors (MAOIs).
- •14. Expected alcohol intake to exceed 1 drink/day within 3 days prior to the days of blood sample collection for PK assessment in the PK phase (i.e., <= 3 days prior to days 19 and 26 of the PK phase) and throughout the timeframe they are taking fluvoxamine (i.e., days 26, 27 and 28 of the PK phase).
- •15. Grapefruits, pomegranates, star fruits, Seville oranges or products containing the juice of each within 3 days prior to the days of blood sample collection for PK assessment in the PK phase (i.e., <= 3 days prior to days 19 and 26 of the PK phase).
- •16. Homeopathic or naturopathic medicines within 5 days prior to the days of blood sample collection for PK assessment in the PK phase (i.e., <= 5 days prior to days 19 and
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