ISRCTN22287432已完成1 期
Phase 1B Study of buparlisib with bortezomib in defined genetic subgroups of patients with relapsed or refractory multiple myeloma
niversity of Birmingham (UK)0 个研究点目标入组 60 人开始时间: 2015年4月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- 性别
- All
入选标准
- •1. Male or female aged at least 16 years of age
- •2. ECOG performance status = 2
- •3. Confirmed diagnosis of relapsed/refractory MM according to International Myeloma Working Group (IMWG) guidelines (2003) with 1-4 prior lines of therapy (i.e., relapsed from plateau phase, or refractory to last therapy). [Note: Prior treatment with bortezomib is permitted, provided the patient achieved at least a partial remission (PR) and had not progressed within 6 months of the last dose of bortezomib].
- •4. Measurable disease as defined by one or more of the following criteria (assessed within 28 days prior to registration):
- •4.1. Serum paraprotein = 5 g/L (for IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (IgA): = 7.5 g/L)
- •4.2. Urine Bence Jones Protein: = 200 mg/24 h
- •4.3. Serum light chain assay: Involved free light chain (FLC) level = 100 mg/L, provided serum FLC ratio is abnormal
- •5. Life expectancy of at least 3 months
- •6. Patient has adequate bone marrow and organ function as defined by the following laboratory values:
- •6.1. Neutrophils = 1.5 x 109/L
- •6.2. Haemoglobin = 90 g/L
- •6.3. Platelets = 100 x 109/L
- •6.4. International normalised ration (INR) = 1.5
- •6.5. Magnesium within normal limits of institution or correctable with supplements
- •6.6. Potassium and calcium (corrected for albumin) within normal limits of institution or correctable with supplements
- •6.7. Phosphorous = LLN or correctable with supplements
- •6.8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 1.5 x ULN upper limit of normal range (or <3.0 x ULN if liver metastases are present)
- •6.9. Total 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’s Syndrome, which is defined as presence of several episodes of unconjugated hyperbilirubinemia with normal results from CBC count (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis
- •6.10. Serum creatinine = 1.5 x ULN. If the serum creatinine is = 1.5 x ULN, then a 24-hour creatinine clearance must be conducted and the result must be = 50ml/minute
- •6.11. Fasting Plasma Glucose = 120 mg/dL or 6.7 mmol/L
- •6.12. HbA1c = 8%
- •7. Patient is able to swallow and retain oral medication
- •8. Patient has signed the Informed Consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirement
- •Expansion phase only: Patients whose bone marrow MM cells stain positive for cyclin D2 and/or phospho-Akt, and/or whose MM cells harbour the t(4;14) or t(14;16) translocations
排除标准
- •1. Impaired cardiac function or clinically significant diseases, including any one of the following:
- •1.1. Symptomatic congestive heart failure
- •1.2. History of documented congestive heart failure (New York Heart Association functional classification IIIIV), documented cardiomyopathy
- •1.3. Left Ventricular Ejection Fraction <50% as determined by ECHO
- •1.4. Acute myocardial infarction =6 months prior to starting study drug
- •1.5. Unstable angina pectoris
- •1.6. Serious uncontrolled cardiac arrhythmia
- •1.7. Symptomatic pericarditis
- •1.8. QTcF >480 msec on the screening ECG (using the QTcF formula)
- •1.9. Currently receiving treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
- •2. Other clinically significant heart disease
- •3. Acute or chronic liver disease
- •4. Acute or chronic renal disease
- •5. Poorly controlled diabetes mellitus
- •6. Impairment of GI function or GI disease that may significantly alter the absorption of BKM)
- •7. Known hypersensitivity to any of the excipients of buparlisib
- •8. History of photosensitivity reactions to other drugs
- •9. Patients with chronic pulmonary disease, including dyspnoea at rest from any cause, or with interstitial lung disease, are excluded from study entry
- •10. Immunocompromised patients, including known seropositivity for HIV, current or chronic hepatitis B and/or hepatitis C infection.[Note: testing is not mandatory to be eligible for the study. However, if subject is at risk for having undiagnosed HBV/HCV (due to history of injection drug use or due to geographic location, for example), testing at screening should be considered]
- •11. Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the investigator’s judgment, contraindicate patient participation in the clinical study (eg. active or uncontrolled severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.)
- •12. Concomitant or/ and previous therapy that precludes enrolment:
- •13. Prior treatment with PI3K or Akt inhibitors
- •14. Patient is concurrently using other approved or investigational antineoplastic agent
- •15. Received antimyeloma therapy within 28 days of starting treatment, except for dexamethasone, which must be stopped at least 48 hours prior to starting treatment (must have recovered to at least grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy)
- •16. Patient who has received wide field radiotherapy = 4 weeks or limited field radiation for palliation = 2 weeks prior to starting study drug or who have not recovered to grade 1 or better from related side effects of such therapy (except alopecia)
- •17. Major surgery within 14 days prior to starting study drug or the patient has not recovered from major side effects of the surgery
- •18. Receiving any of the following drugs at the time
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