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

Investigating the occurrence of everolimus long-term side effects by follow up of everolimus trough blood concentrations. - Everolimus TDM to predict long-term toxicity

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50487

Enrollment

Registered

2017-05-01

Start date

2017-09-27

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mRCC en (p)NET Breast cancer renal cell carcinoma and neuroendocrine tumours

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. The difference in percentage of patients with a high everolimus trough level (i.e. > 18 ng/mL) experiencing NCI-CTCAE v4.0 grade 2, 3 or 4 late AEs (i.e. from treatment period	—

Countries

Netherlands

Outcome results