Investigating the occurrence of everolimus long-term side effects by follow up of everolimus trough blood concentrations.

Phase 4

Recruiting

• Conditions: mRCC en (p)NET; Breast cancer; renal cell carcinoma and neuroendocrine tumours; 10006291

• Registration Number: NL-OMON50487
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

-Patients currently treated with everolimus for any type of cancer, such as the
EMA registered indications i.e. advanced (Hormone-Receptor [HR]-positive,
HER2-negative) breast cancer, metastatic renal cell carcinoma (mRCC) or
neuroendocrine tumour (NET) of pancreatic, gastrointestinal or lung origin.
-Aged 18 or above
-Able and willing to sign the informed consent

Exclusion Criteria

-No informed consent
-Alactasia
-Lenvatinib combination therapy with everolimus (mRCC)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in percentage of patients with a high everolimus trough level<br /><br>(i.e. > 18 ng/mL) experiencing NCI-CTCAE v4.0 grade 2, 3 or 4 late AEs (i.e.<br /><br>toxicity reported from >= 12 weeks onward, e.g. pneumonitis, anorexia, anemia)<br /><br>compared to participants with lower trough concentrations. </p><br>