Phase I study of nelfinavir in combination with temsirolimus in the treatment of patients with advanced cancers, including second line renal cell cancer

Not yet recruiting

• Conditions: advanced cancer; metastatic cancer; 10027655

• Registration Number: NL-OMON33441
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 21

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 < 150*mol/L
· Able and willing to give written informed consent according to ICH/GCP, and national/local
regulations.
· Able to swallow and retain oral medication
· Able and willing to undergo blood sampling for pharmacokinetic and pharmacogenetic
analysis
· Absence of any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule; those conditions
should be discussed with the patient before registration in the trial

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> - pharmacokinetics (steady state concentration) and toxicity/feasibility of<br /><br>the combination of temsirolimus and nelfinavir</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- tumor response<br /><br>- duration of response<br /><br>- time to progression<br /><br>- toxicity profile<br /><br>- level of PI3K /Akt/mTOR cascade activation in white blood cells<br /><br>- gene profile of drug elimination gene polymorphism of the patients and its<br /><br>association with the pharmacokinetic profile</p><br>