EUCTR2011-000454-32-GB进行中（未招募）1 期
A single arm phase IIa study (with combination safety run-in) to assess the safety and efficacy of AZD4547 in combination with either anastrozole or letrozole in ER positive breast cancer patients who have progressed on treatment with anastrozole or letrozole - RADICA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
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
入选标准
- •Patients must fulfil all of the following criteria.
- •1.Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
- •2.Aged = 25 years of age (N.B. in line with other studies with AZD4574 and due to concerns of possible effects on the immature skeleton)
- •3.Post menopausal women. Women will be considered postmenopausal if they have had a bilateral oophorectomy or the following specific requirements apply:
- •Safety run-in:
- •oWomen under 50 years old would be considered post-menopausal if they have been amenorrhoeic for 24 months and have follicle-stimulating hormone (FSH) and oestradiol levels in the post-menopausal range. Patients with prior exposure to depot LHRH analogues must be 24 months or more following the last administration
- •oWomen aged 50 years and older would be considered post-menopausal if they have been amenorrhoeic for 12 months and patients with prior exposure to depot LHRH analogues must be 12 months or more following the last administration
- •oWomen rendered amenorrhoeic by adjuvant chemotherapy, who were premenopausal or perimenopausal prior to chemotherapy, must have been amenorrhoeic for at least 24 months
- •oWomen under 50 years old would be considered post-menopausal if they have been amenorrhoeic for 24 months and have follicle-stimulating hormone (FSH) and oestradiol levels in the post-menopausal range.
- •oWomen aged 50 years and older would be considered post-menopausal if they have been amenorrhoeic for 12 months
- •oWomen rendered amenorrhoeic by adjuvant chemotherapy, who were premenopausal or perimenopausal prior to chemotherapy, must have been amenorrhoeic for at least 24 months
- •oPerimenopausal women rendered amenorrhoeic from exposure to depot LHRH analogues*
- •*Patients must have taken LHRH analogues for at least 6 months
- •4.Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
- •5.Histological confirmation of breast cancer with documented positive oestrogen receptor status (ER+) of primary or metastatic tumour tissue according to local laboratory parameters
- •6.Phase IIa: Mandatory provision of tumour biopsy for assessment of oncology biomarkers
- •7.Fulfils criteria for previous treatment of breast cancer*:
- •Safety run-in:
- •oRelapse during a single regimen of adjuvant endocrine therapy with either anastrozole or letrozole
- •oProgression during first line endocrine therapy with a non-steroidal AI for advanced breast cancer**. Co-administration of a targeted agent with the non-steroidal AI is permitted providing all toxicities have recovered to CTCAE Grade 1 or below
- •1 prior regimen of chemotherapy in the advanced setting is permitted. Chemotherapy administered in the adjuvant setting is permitted
- •oProgressing or progression at some point during breast cancer treatment on endocrine therapy with a non-steroidal AI.*** Co-administration of a targeted agent with the non-steroidal AI is permitted providing all toxicities have recovered to CTCAE Grade 1 or below.
排除标准
- •1.Treatment with any of the following:
- •a.Safety run-in: more than 1 regimen of endocrine therapy for advanced breast cancer
- •b.previous exposure to any FGFR inhibitor
- •c.Safety run in: more than 1 prior regimen of chemotherapy for advanced breast cancer.
- •d.potent inhibitors or inducers of CYP3A4 or CYP2D6, or substrates of CYP3A4 within 2 weeks prior to first dose of study treatment (3 weeks for St John’s Wort)
- •e.major surgery within 4 weeks prior to first dose of study treatment
- •f.radiotherapy with a wide field of radiation within 4 weeks prior to first dose of study treatment; or radiotherapy with a limited field of radiation for palliation within 2 weeks before the first dose of study treatment
- •2.With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at time of starting study
- •3.Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment
- •4.Any evidence of severe or uncontrolled systemic diseases or active infection
- •5.Any of the following cardiac criteria:
- •a.Resting corrected QT interval (QTc) >470 ms
- •b.Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block
- •c.Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, 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
- •6.Inadequate bone marrow reserve or organ function as defined by any one of the following parameters:
- •Haemoglobin < 9.0 g/dL (<90.0 g/L)
- •Absolute neutrophil count (ANC) < 1.5 x 109 /L
- •Platelet count < 100 x 109 /L
- •Alanine aminotransferase > 2.5 x ULN if no demonstrable liver metastases or > 5 x ULN in the presence of liver metastases
- •Aspartate aminotransferase > 2.5 x ULN if no demonstrable liver metastases or > 5 x ULN in the presence of liver metastases
- •Total bilirubin > 1.5 x ULN if no demonstrable liver metastases or > 3 x ULN in the presence of liver metastases
- •Creatinine > 1.5 times ULN or creatinine clearance <50ml/min
- •Corrected calcium > ULN
- •Phosphate > ULN
- •7.Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated IMP or previous significant bowel resection that would preclude absorption of AZD4547 or anastrozole or letrozole
- •8.History of hypersensitivity to anastrozole or letrozole
- •9.History of another malignancy within 5 yrs prior to starting study treatment, except adequately treated basal or squamous cell carcinoma of the skin, carcinoma of the cervix and the disease under study
- •10.Any of the following ophthalmological criteria:*
- •oCurrent evidence or previous history of retinal pigmented epithelium detachment (RPED)
- •oPrevious laser treatment or intra-ocular injection for treatment of mac
研究者
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