Study of Nelfinavir and Temsirolimus in Patients With Advanced Cancers
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
In the present study the investigators want to explore the safety, pharmacokinetics, and
activity of the combination of temsirolimus and nelfinavir, both agents with PI3K /Akt/mTOR
inhibiting activity, in patients with advanced malignancies.Temsirolimus has proven anti
tumoral activity by mTOR inhibition. Nelfinavir is a potential inhibitor of Akt. Combining
both agents might prevent upregulation of the P13k pathway and increase the anti-cancer
activity of temsirolimus. The strong CYP3A4 inhibition of nelfinavir and the dependence of
temsirolimus on CYP3 A4 metabolism makes a dose finding study essential. The investigators
will also look at the prospective value of biomarkers of activity and the outcome of the
treatment.
Phase:
Phase 1
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)