search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number19433
- NTR NumberNTR4780
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-sep-2014
- Secondary IDs2014-000281-21 M14EEP
- Public TitleImproving brain penetration of radiolabeled TKI PET tracers through blood brain barrier transporter inhibition
- Scientific TitleImproving CNS penetration of radiolabeled TKI PET tracers through PgP/BCRP inhibition
- ACRONYMM14EEP
- hypothesisThe primary objective of this study is to obtain clinical proof of principle that the Addition of a PgP/BCRP inhibitor increases CNS concentrations of tyrosine kinase inhibitors by inhibition of drug efflux transporter function in the blood brain barrier
- Healt Condition(s) or Problem(s) studiedCancer, Brain metastases, Blood Brain Barrier
- Inclusion criteriaThe 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- 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 20-mrt-2014
- planned closingdate31-dec-2014
- Target number of participants8
- Interventions- 2 11C-erlotinib PET scans. 1 with administration of a PGP/BCRP inhibitor and 1 without.
- 1 MRI of the brain.
- Primary outcomeImproved CNS penetration of 11C erlotinib after PGP/BCRP inhibitor administration.
- Secondary outcomeNA
- Timepoints11C-erlotnib PET scan on 2 successive days.
Follow up visit 7+-2 days afterwards.
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. N. Steeghs
- CONTACT for SCIENTIFIC QUERIESDr. N. Steeghs
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL)
- Publications
- Brief summaryThe primary objective of this study is to obtain clinical proof of principle that the addition of a PgP/BCRP inhibitor increases CNS concentrations of tyrosine kinase inhibitors by inhibition of drug efflux transporter function in the blood brain barrier.
Every patient will undergo two PET scans. For both scans an intravenous bolus of [11C]erlotinib will be administered. For the second scan patients will be instructed to take 1000 mg of a PGP/BCRP inhibitor orally. This will enable us to measure the uptake of [11C]erlotinib in the brain with and without PgP/BCRP inhibition.
- Main changes (audit trail)
- RECORD10-sep-2014 - 22-mei-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl