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Improving brain penetration of radiolabeled TKI PET tracers through blood brain barrier transporter inhibition

Improving CNS penetration of radiolabeled TKI PET tracers through PgP/BCRP inhibition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25665
Enrollment
8
Registered
2014-09-10
Start date
2014-03-20
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Cancer Brain metastases Tyrosinse Kinase Inhibitors Drug Transporters

Interventions

- 2 11C-erlotinib PET scans. 1 with administration of a PGP/BCRP inhibitor and 1 without. - 1 MRI of the brain.

Sponsors

Netherlands Cancer Institute - Antoni van Leeuwenhoek
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The study population consists of cancer patients with advanced or metastatic solid tumors for whom no standard therapy is available or for whom a TKI which is a PgP/BCRP substrate is a standard therapeutic option (erlotinib, sunitinib, imatinib, gefitinib, sorafenib, lapatinib, crizotinib, vemurafenib).

Exclusion criteria

Exclusion criteria: - Known brain metastases; - Patients who have had previous treatment with central nervous system irradiation; - Treatment with the tyrosine kinase inhibitor used as TKI PET tracer within three half lives before the PET scans; - Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance; - Patients are not allowed to use co-medication with PgP or BCRP modulators (including OTC medication) - Patients are also not allowed to use co-medication which are PgP or BCRP substrates as this may lead to increased toxicity. - Known hypersensitivity to erlotinib, elacridar or any excipients used in the formulation of either IMPs. - Known contra-indications for a MRI scan.

Design outcomes

Primary

MeasureTime frame
Improved CNS penetration of 11C erlotinib after PGP/BCRP inhibitor administration.

Contacts

Public ContactN. Steeghs

The Netherlands Cancer Institute Department of Medical Oncology Plesmanlaan 121

n.steeghs@nki.nl+31 (0)20 5122570

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)