Prospective Study of UDP-gluconoryltransferase 2B17 Genotype as a Predictive Marker of Exemestane PK and PD
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|ClinicalTrials.gov Identifier: NCT01655004|
Recruitment Status : Recruiting
First Posted : August 1, 2012
Last Update Posted : June 22, 2016
|Condition or disease||Intervention/treatment|
|Breast Carcinoma||Drug: Exemestane|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Study of UDP-gluconoryltransferase (UGT) 2B17 Genotype as a Predictive Marker of Exemestane Pharmacokinetics and Pharmacodynamics in Asian Women With Hormone Receptor-positive Advanced Breast Cancer|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||August 2018|
Experimental: exemestane standard treatment
Patients will receive exemestane 25mg daily orally after a meal until progression of disease, intolerable toxicities, voluntary withdrawal or termination of the study.
Exemestane is commercially available and will be obtained locally from the manufacturer. There are no experimental treatments in this study.
Other Name: trade name Aromasin
- Correlation of UGT2B17*2 deletion genotype with clinical benefit rate (CBR) [ Time Frame: 24 weeks ]The correlation of genotype (UGT2B17 *2/*2 versus those with at least one wild-type allele) with clinical benefit rate (CBR), defined as the percentage achieving CR, PR and SD in patients with measurable disease or the absence of disease progression in patients with non-measurable disease, lasting at least 24 weeks.
- Correlation of UGT2B17*2 deletion genotype with exemestane pharmacokinetics, objective response rates (ORR), progression-free survival (PFS), overall survival (OS) and musculoskeletal toxicities [ Time Frame: 24 months ]
The correlation of genotype (UGT2B17 *2/*2 versus those with at least one wild-type allele) with:
- Objective response rates (ORR), as defined by a best overall response of CR or PR.
- Progression-free survival (PFS), as defined by the time from the date of study enrollment until the first date of documented disease progression or death due to any cause, whichever occurs first.
- Overall survival (OS) as defined by the time from the date of study enrollment until the date of death due to any cause.
- Grade 2 and above musculoskeletal toxicities, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.
- Pharmacokinetic parameters, in particular, AUC of exemestane-17-O-glucuronide, 17-dihydroexemestane and their ratio.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655004
|Contact: Andrea LA Wong, MBBS||(65) 6772 firstname.lastname@example.org|
|Contact: Soo Chin Lee, MBBS||(65) 6772 email@example.com|
|National University Hospital||Recruiting|
|Singapore, Singapore, 119074|
|Contact: Andrea LA Wong, MBBS (65) 6772 5934 firstname.lastname@example.org|
|Sub-Investigator: Soo Chin Lee, MBBS|
|Sub-Investigator: Siew Eng Lim, MBBS|
|Sub-Investigator: Sing Huang Tan, MBBS|
|Principal Investigator:||Andrea LA Wong, MBBS||National University Hospital, Singapore|