EUCTR2010-021220-10-IT进行中（未招募）不适用
A Randomised Double-blind Phase IIa Study (with Combination Safety Run-in) to Assess the Safety and Efficacy of AZD4547 in Combination with Exemestane vs. Exemestane Alone in ER+ Breast Cancer Patients with FGFR1 Polysomy or Gene Amplification Who Have Progressed Following Treatment with One Prior Endocrine Therapy (Adjuvant or First-line Metastatic). - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ASTRAZENECA
- 入组人数
- 72
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
- •1. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses If a patient declines to participate in any voluntary exploratory research component of the study, there will be no penalty or loss of benefit to the patient and they will not be excluded from other aspects of the study 2. Post -menopausal women. Women will be considered post-menopausal if they have had a bilateral oophorectomy or the following specific requirements apply: a. Women under 50 years old would be consider 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 b. Women aged 50 years and older would be consider 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 c. Women rendered amenorrhoeic by adjuvant chemotherapy, who were premenopausal or perimenopausal prior to chemotherapy, must have been amenorrhoeic for at least 24 months 3. World Health Organisation performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks 4. Histological confirmation of breast cancer, with documented positive oestrogen receptor status (ER+) of primary or metastatic tumour tissue, according to the local laboratory parameters Randomised phase IIa: Mandatory provision of tumour biopsy for AZ approved laboratory confirmation of FGFR1 polysomy or gene amplification (FISH score = 4) 5. Fulfils specific criteria for previous treatment of breast cancer: a. Relapsing during, or within 12 months of completion of, a single regimen of adjuvant endocrine therapy with non-steroidal AI and/or tamoxifen or b. Progression following first line endocrine therapy with a non-steroidal AI and/or tamoxifen 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 Randomised phase IIa: Chemotherapy administered in the adjuvant setting is permitted *Advanced breast cancer: metastatic disease or locally advanced disease which is not amenable to treatment with curative intent. 6. Randomised phase IIa: At least one lesion, not previously irradiated, that can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes which must have short axis = 15 mm) with CT or MRI and which is suitable for accurate repeated measurements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients must not enter the study if any of the following exclusion criteria are fulfilled 1. Treatment with any of the following: a. More than one regimen of endocrine therapy for advanced breast cancer (oophorectomy, ovarian ablation and LH-RH analogue therapy do not count as endocrine therapy for this study) b. Previous exposure to exemestane or any agent known to inhibit FGFRs c. Safety run-in: More than 1 prior regimen of chemotherapy for advanced breast cancer d. Randomised phase IIa: Any prior chemotherapy for advanced breast cancer e. Potent inhibitors or inducers of CYP3A4 or CYP2D6 or substrates of CYP3A4 within 2 weeks before the first dose of study treatment (3 weeks for St John’s Wort) f. Major surgery (excluding placement of vascular access) within 4 weeks before the first dose of study treatment g. Radiotherapy with a wide field of radiation within 4 weeks 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 the time of starting study treatment 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. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required 5. Any of the following cardiac criteria: h. Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs) i. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block j. 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 demonstrated by any of the following laboratory values: k. Absolute neutrophil count < 1.5 x 109/L l. Platelet count < 100 x 109/L m. Haemoglobin < 90 g/L n. Alanine aminotransferase > 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases o. Aspartate aminotransferase > 2.5 times ULN if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases p. Total bilirubin > 1.5 times ULN if no liver metastases or > 3 times ULN in the presence of liver metastases q. Creatinine >1.5 times ULN concurrent with creatinine clearance < 50 ml/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is > 1.5 times ULN r. Corrected calcium > ULN s. Phosphate > ULN 7. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD4547 / exemestane
研究者
相似试验
进行中（未招募）
不适用
Safety and efficacy of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ Breast Cancer patientsER+ Breast cancerMedDRA version: 16.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-021220-10-HUAstraZeneca AB120
进行中（未招募）
不适用
Safety and efficacy of AZD4547 in combination with exemestane vs. exemestane alone in ER+ Breast Cancer patientsEUCTR2010-021220-10-DEAstraZeneca AB89
进行中（未招募）
不适用
Safety and efficacy of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ Breast Cancer patientsER+ Breast cancerMedDRA version: 15.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-021220-10-GBAstraZeneca AB120
进行中（未招募）
不适用
A Randomised Double-blind Phase IIa Study (with Combination Safety Run-in) to Assess the Safety and Efficacy of AZD4547 in Combination with Exemestane vs. Exemestane Alone in ER+ Breast Cancer Patients with FGFR1 Polysomy or Gene Amplification Who Have Progressed Following Treatment with One Prior Endocrine Therapy (Adjuvant or First-line Metastatic)MedDRA version: 12.1Level: LLTClassification code 10006187Term: Breast cancerBreast CancerEUCTR2010-021220-10-FRAstraZeneca AB72
进行中（未招募）
不适用
A Randomised Double-blind Phase IIa Study (with Combination Safety Run-in) to Assess the Safety and Efficacy of AZD4547 in Combination with Exemestane vs. Exemestane Alone in ER+ Breast Cancer Patients with FGFR1 Polysomy or Gene Amplification Who Have Progressed Following Treatment with One Prior Endocrine Therapy (Adjuvant or First-line Metastatic)Breast CancerEUCTR2010-021220-10-CZAstraZeneca AB72