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A pharmacokinetic evaluation of the addition of Aprepitant to the Cisplatin - Etoposide (CE) treatment of patients with metastatic lung carcinoma (ACE)

Phase 4
Conditions
misselijkheid en braken na toedienen cytostatica kuur
nausea and vomiting
10027656
Registration Number
NL-OMON31383
Lead Sponsor
niversitair Medisch Centrum Sint Radboud
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

Subject is at least 18 and no older than 75 years of age
Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
Subject has an indication for treatment with CE regimen
Subject is expected to receive at least 2 cycles of CE regimen
Subject is able to swallow capsules

Exclusion Criteria

Documented history of sensitivity/idiosyncrasy to aprepitant capsules or exipients
Relevant history or current condition that might interfere with drug absorption
History or current abuse of drugs, alcohol or solvents
Inability to understand the nature and extent of the trial and the procedures required
Participation in a drug trial within 30 days before the first dose
Febrile illness within 3 days before the first dose
Concomitant use of agents that are known to interfere with aprepitant pharmacokinetics
Abnormal liver or renal function

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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