advanced cancer metastatic cancer
Conditions
Interventions
Treatment with BID nelfinavir orally
Treatment with weekly temsirolimus intravenously
Blood sampling
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with histological or cytological confirmed malignancies · ECOG / WHO performance status of 0-2 · Age 18 years · Life expectancy of at least 3 months · Minimal acceptable safety laboratory values defined as · WBC 3.0 x 109 /L · Platelet count 100 x 109 /L · Hepatic function as defined by serum bilirubin 1.5 x ULN, ALT or AST 2.5 x ULN, in case of liver metastases 5 x ULN · Renal function as defined by creatinine
Exclusion criteria
Exclusion criteria: - Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up · Women who are pregnant or breast feeding · Women of childbearing potential who refuse to use a reliable contraceptive method throughout the study · Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator · Any other medical condition that would interfere with study procedures and/or decrease safety of the protocol treatment · Concomitant use of strong CYP3A4 inhibitors, CYP3A4 inducers or CYP substrates (see section 1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - pharmacokinetics (steady state concentration) and toxicity/feasibility of the combination of temsirolimus and nelfinavir | — |
Secondary
| Measure | Time frame |
|---|---|
| - tumor response - duration of response - time to progression - toxicity profile - level of PI3K /Akt/mTOR cascade activation in white blood cells - gene profile of drug elimination gene polymorphism of the patients and its association with the pharmacokinetic profile | — |
Countries
Netherlands
Outcome results
None listed