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Influence of Exceptional Patient Characteristics on Everolimus Exposure

Information source: Radboud University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Neoplasms

Intervention: everolimus dose escalation (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Radboud University

Official(s) and/or principal investigator(s):
Carla van Herpen, MD, PhD, Principal Investigator, Affiliation: Radboud university medical center, department of medical oncology
Nielka van Erp, PharmD, PhD, Principal Investigator, Affiliation: Radboud university medical center, department of Pharmacy

Overall contact:
Carla van Herpen, MD, PhD, Email: Carla.vanHerpen@radboudumc.nl

Summary

A study to determine whether everolimus pharmacokinetics in elderly and obese patients is different compared to control patients. 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.

Clinical Details

Official title: Influence of Exceptional Patient Characteristics on Everolimus Exposure

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: everolimus AUC

Secondary outcome:

correlation between early metabolic response and PFS

correlation between early metabolic response and AUC

effect dose escalation on metabolic respons

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not

amenable to curative treatment by surgery or radiotherapy.

- 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:

- Patients aged ≥ 70 years AND BMI ≥ 30 kg/m2

- 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

Locations and Contacts

Carla van Herpen, MD, PhD, Email: Carla.vanHerpen@radboudumc.nl

Maasziekenhuis Pantein, Boxmeer, Netherlands; Recruiting
Yvonne Kamm, MD, PhD

Maastricht University Medical Center, Maastricht, Netherlands; Recruiting
Maaike de Boer, MD, PhD, Principal Investigator

St. Antonius Ziekenhuis, Nieuwegein, Netherlands; Recruiting
Paul de Jong, MD, PhD

Radboud university medical center, Nijmegen, Netherlands; Recruiting
Annelieke Willemsen, MD, Email: annelieke.willemsen@radboudumc.nl
Carla van Herpen, MD, PhD, Principal Investigator

Bernhoven Ziekenhuis, Uden, Netherlands; Recruiting
Allert Vos, MD, Principal Investigator

Isala Klinieken, Zwolle, Netherlands; Recruiting
Jan Willem de Groot, MD, PhD

Additional Information

Starting date: August 2013
Last updated: May 8, 2015

Page last updated: August 23, 2015

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