drugset / Trial / NCT01079286
Study of Nelfinavir and Temsirolimus in Patients With Advanced Cancers
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2009-06
- Primary completion
- 2011-05
- Completion
- 2011-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nelfinavir | Other / unclassified | 250 mg | Oral |
| Subject | Temsirolimus | Small molecule | — | Intravenous |