Influence of Exceptional Patient Characteristics on Everolimus Exposure
NCT ID: NCT01948960
Last Updated: 2018-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
56 participants
INTERVENTIONAL
2013-08-31
2018-01-15
Brief Summary
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Furthermore the investigators will investigate the relation between metabolic response assessed with \[18F\] Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) and everolimus exposure and clinical benefit.
The investigators will explore whether dose escalation in patients who are hypothetically underexposed will result in an increase in metabolic response.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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standard care
everolimus dose is continued independently of everolimus AUC
No interventions assigned to this group
everolimus dose escalation
patients with an AUC below mean will have dose escalation of everolimus based on their AUC
everolimus dose escalation
patients with an AUC below mean will have dose escalation of everolimus based on their AUC
Interventions
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everolimus dose escalation
patients with an AUC below mean will have dose escalation of everolimus based on their AUC
Eligibility Criteria
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Inclusion Criteria
* Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
* Postmenopausal women
* Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment.
* Progression following a non-steroidal aromatase inhibitor
* Falling into one of the following categories
* elderly patients (age ≥ 70 years and BMI \< 30 kg/m2); or
* obese patients (BMI ≥ 30 kg/m2 and age \< 70 years); or
* control patients (BMI \< 30 kg/m2 and age \< 70 years);
* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x ULN
* Adequate renal function: calculated creatinine clearance, as estimated by GFR using the MDRD formula, is ≥ 30ml/min/1.73m2
* Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100)
* Patient is willing and able to sign the Informed Consent Form prior to screening evaluations
Exclusion Criteria
* HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
* Previous treatment with exemestane or mTOR inhibitors. Except for the treatment with exemestane in the adjuvant setting.
* Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
* Patients with a known history of HIV seropositivity.
* Any severe and / or uncontrolled medical conditions such as:
* Unstable angina pectoris, serious uncontrolled cardiac arrhythmia
* Patients with severe hepatic impairment (Child-Pugh A/B/C)
* Uncontrolled diabetes mellitus
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
* Patients who test positive for hepatitis B or C
* Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A within the last 5 days prior to enrollment
* History of non-compliance to medical regimens
* Patients unwilling to or unable to comply with the protocol
18 Years
FEMALE
No
Sponsors
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Novartis
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Carla van Herpen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud university medical center, department of medical oncology
Nielka van Erp, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud university medical center, department of Pharmacy
Locations
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Maasziekenhuis Pantein
Boxmeer, , Netherlands
Spaarne Gasthuis
Hoofddorp, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Radboud university medical center
Nijmegen, , Netherlands
Bernhoven Ziekenhuis
Uden, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Countries
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References
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Willemsen AECAB, de Geus-Oei LF, de Boer M, Tol J, Kamm Y, de Jong PC, Jonker MA, Vos AH, Grootjans W, de Groot JWB, Mulder SF, Aarntzen EHJG, Gerritsen WR, van Herpen CML, van Erp NP. Everolimus Exposure and Early Metabolic Response as Predictors of Treatment Outcomes in Breast Cancer Patients Treated with Everolimus and Exemestane. Target Oncol. 2018 Oct;13(5):641-648. doi: 10.1007/s11523-018-0596-8.
Related Links
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Everolimus Exposure and Early Metabolic Response as Predictors of Treatment Outcomes in Breast Cancer Patients Treated with Everolimus and Exemestane
Other Identifiers
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UMCNONCO201301
Identifier Type: -
Identifier Source: org_study_id