NL-OMON33441Not yet recruitingNot Applicable
Phase I study of nelfinavir in combination with temsirolimus in the treatment of patients with advanced cancers, including second line renal cell cancer - I-NET
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 21
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •· 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)
Investigators
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