EUCTR2013-001521-43-GB进行中（未招募）不适用
A Phase II, double blind, randomised, placebo-controlled study of the AKT inhibitor AZD5363 in combination with paclitaxel in triple-negative advanced or metastatic breast cancer - PAKT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- Female
入选标准
- •Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- •1. Written informed consent prior to admission to this study
- •2. Women, age = 18 years
- •3. Histologically confirmed breast cancer
- •4. Metastatic or locally recurrent disease; locally recurrent disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible).
- •5. Patients must have
- •at least one lesion, not previously irradiated, that can be measured accurately at baseline as =10 mm in the longest diameter (except lymph nodes which must have short axis =15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements, or
- •lytic or mixed (lytic + sclerotic) bone lesions in the absence of measurable disease as defined above; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible
- •6. Radiological or clinical evidence of recurrence or progression
- •7. Triple-negative disease, defined as tumour cells being
- •negative for ER with <1% of tumour cells positive for ER on IHC or IHC score (Allred) of =2
- •negative for PR with <1% of tumour cells positive for PR on IHC or IHC score (Allred) of =2 or PR unknown, and
- •negative for HER2 with 0,1+ or 2+ intensity on IHC and no evidence of amplification on ISH.
- •8. Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing
- •9. Patients must be able to swallow and retain oral medication
- •10. Haematologic and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to randomisation
- •ANC = 1.5x 109/L, and platelet count = 100 x 109/L
- •Serum creatinine < 1.5 times the upper limit of normal (ULN)
- •Bilirubin level < 1.5 x ULN
- •AST or ALT <2.5 x ULN or <5 x ULN in the presence of liver metastases
- •11. ECOG performance status 0-2
- •12. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had a hysterectomy, bilateral oopheroctemy, bilateral tubular ligation or is post-menopausal (total cessation of menses for = 1 year; if the patient is of childbearing potential, she must have a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception (for example, intrauterine device [IUD], birth control pills unless clinically contraindicated, or barrier device) beginning 2 weeks before the first dose of investigational product and for at least 1 month after AZD5363/placebo treatment discontinuation or for at least 6 months after paclitaxel treatment discontinuation, whichever is longer.
- •13. Willing and able to provide written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
- •1. Patients with confirmed brain metastases or a history of primary central nervous system tumors or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases. Patients with treated brain metastases that are asymptomatic and have been clinically stable for 3 months will be eligible for protocol participation
- •2. Prior chemotherapy for metastatic breast cancer
- •3. Radiotherapy with a wide field of radiation (greater than or equal to 30% marrow or whole pelvis or spine) within 4 weeks before the first dose of study medication (AZD5363/placebo)
- •4. Prior treatment with PI3K inhibitors, AKT inhibitors or mTOR inhibitors.
- •5. Prior treatment with paclitaxel or docetaxel in the (neo)adjuvant setting within 12 months from the end of paclitaxel or docetaxel treatment and inclusion into this study
- •6. Preexisting sensory or motor polyneuropathy = Grade 2 according to NCI CTC
- •7. Malabsorption syndrome or other condition that would interfere with enteral absorption
- •8. Clinically significant pulmonary dysfunction
- •9. QTc Prolongation defined as a QTc interval >470 msecs or other significant abnormalities in rhythm, conduction or morphology of resting ECG including 2nd degree (type II) or 3rd degree AV block or bradycardia (ventricular rate <50 beats/min)
- •10. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval.
- •11. Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure NYHA Grade =2, or Cardiac ejection fraction outside institutional range of normal or <50%
- •12. Clinically significant abnormalities of glucose metabolism as defined by any of the following
- •Diagnosis of diabetes mellitus type I or II (irrespective of management).
- •Glycosylated haemoglobin (HbA1C) =8.0% at screening (64 mmol/mol) (conversion equation for HbA1C [IFCC-HbA1C (mmol/mol) = [DCCT-HbA1C (%) – 2.15] x 10.929)
- •Fasting Plasma Glucose = 7.0mmol/L (126 mg/dL) at screening. Fasting is defined as no caloric intake for at least 8 hours.
- •13. Patients with proteinuria (3+ on dipstick analysis or > 500mg/24 hours) or creatinine > 1.5 x ULN concurrent with creatinine clearance <50 mL/min
- •14. Exposure to potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John’s Wort) (for details please refer to Appendix 2).
- •15. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry.
- •16. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator’s opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining inf
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