NL-OMON41877
Recruiting
Not Applicable
The OPTIMAL study: Optimizing Performance of afiniTor by splitting Intake Moments and decreasing Adverse events whilst maintaining outcome quaLity. - N14OPT: The OPTIMAL study, 10 mg QD vs 5 mg BID Everolimus.
Antoni van Leeuwenhoek Ziekenhuis0 sites10 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age \>\= 18 years;
- •2\.Able and willing to give written informed consent;
- •3\.Able and willing to undergo blood sampling for PK analysis;
- •4\.Histopathologically confirmed advanced hormone positive, HER2 negative, breast cancer for which everolimus in combination with exemestane is considered standard of care.
- •5\.Minimal acceptable safety laboratory values
- •a.ANC of \>\= 1\.5 x 10^9 /L
- •b.Platelet count of \>\= 100 x 10^9 /L
- •c.Hepatic function as defined by serum bilirubin \<\= 1\.5 x ULN, ASAT and ALAT \<\=2\.5 x ULN
- •d.Renal function as defined by serum creatinine \<\= 1\.5 x ULN or creatinine clearance \>\= 50 mL/min (by Cockcroft\-Gault formula);
Exclusion Criteria
- •1\.Woman who are pregnant or breast feeding;
- •2\.Known hypersensitivity to any of the study drugs or excipients;
- •3\.Unable or unwilling to undergo pharmacokinetic sampling;
- •4\.Use of any concomitant medication (including OTC and herbal medication) which may induce or inhibit function of CYP3A4, including but not limited to efavirenz, etravirine, nevirapine, rifampicine, boceprevir, claritromycine, elvitegravir, erytromycine, fluconazol, itraconazol, ketoconazol, posaconazol, telaprevir, verapamil, cyclosporine, voriconazol, dexamethason, St John\*s Wort and grapefruit juice;
- •5\.Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance;
- •6\.Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment\-related complications;
- •7\.Legal incapacity
Outcomes
Primary Outcomes
Not specified
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