AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer
This trial is active, not recruiting.
|Condition||advanced metastatic breast cancer|
|Start date||May 2012|
|End date||August 2016|
|Trial size||110 participants|
|Trial identifier||NCT01597388, BRE-196, D2270C00005|
The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Sarasota, FL||Research Site||no longer recruiting|
|Detroit, MI||Research Site||no longer recruiting|
|Detroit, MI||Wayne State University / Karmanos Cancer Institute||no longer recruiting|
|Oklahoma City, OK||Research Site||no longer recruiting|
|Greenville, SC||Research Site||no longer recruiting|
|Nashville, TN||Research Site||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
|Primary purpose||basic science|
Assessment of safety and tolerability of AZD2014, when given in combination with fulvestrant, by assessment of: adverse events, clinical chemistry and haematology laboratory parameters, ECG data, vital signs and physical examination.
time frame: From screening until the end of the follow up period, an expected average of 6 months
Determination of the steady state/multiple dose PK profile of AZD2014 in combination with fulvestrant by assessments including:maximum plasma concentration of AZD2014 (Cmax),time to Cmax and area under the plasma concentration-time curve (AUC).
time frame: At multiple time-points on Day 22 of multiple continuous dosing, Day 23 of intermittent Day 1 and 2 dosing or the fourth day of intermittent Day 1 and 4 dosing
Determination of the minimum plasma concentration at steady state of fulvestrant when administered in combination with AZD2014.
time frame: Samples will be obtained on Day 29 and Day 57 of multiple dosing
Determination of the single dose PK profile of AZD2014,by assessments including: maximum plasma concentration (Cmax),time to Cmax,terminal rate constant half life,area under the plasma concentration-time curve (AUC0-12 and AUC0-24).
time frame: At multiple time-points: for continuous dosing, on the day of single dosing (up to 5 days prior to the start of multiple dosing); for Day 1 & 2 intermittent, on the first dose of week 3; for Day 1 & 4 intermittent, on the first day of dosing.
Obtain a preliminary assessment of the anti-tumour activity of AZD2014, when given in combination with fulvestrant, by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1)
time frame: At screening and every 8 weeks until progression, an expected average of 6 months
Female participants from 18 years up to 100 years old.
Inclusion Criteria: - Provision of signed and dated written informed consent prior to any study specific procedures, sampling analysis - Aged at least 18 - At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment - Histological or cytological confirmation of an ER+ advanced metastatic breast cancer tumour that is eligible for treatment with fulvestrant - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Patients must have evidence of non-child-bearing potential. Exclusion Criteria: - Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 14 days of starting study treatment (not including palliative radiotherapy at focal sites) - Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study. - Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions. - Patients with diabetes type 1 or uncontrolled type II (HbA1c > 8% assessed locally)
|Official title||A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination With Intramuscular (IM) Fulvestrant to Patients With Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer|
|Description||A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination with Intramuscular (IM) Fulvestrant to Patients with Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer.|
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