Clinical trial · Interventional
Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients
A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).
NCT00588835CI-TRIAL-00048549ACEterminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether aprepitant can be used in the Cisplatin - Etoposide chemotherapeutic regimen.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aprepitant | Drug | — | UNRESOLVED |
| Dexamethasone and Ondansetron during CE-treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Aprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment.
- interventionNames
- Drug: aprepitant
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- CE cycle with standard anti-emetic regimen.
- interventionNames
- Drug: Dexamethasone and Ondansetron during CE-treatment
Primary outcomes (1)
- measure
- plasma concentrations of etoposide will be measured
- timeFrame
- just before etoposide infusion, at 0.5, 1,4,6,8 and 24 hours and 32 hours after dosing on study days 1 and 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * between 18 and 75 years of age * able and willing to sign informed consent form * indication for treatment with CE regimen * subject is expected to receive at least 2 cycles of CE regimen * able to swallow capsules Exclusion Criteria: * history of sensitivity/idiosyncrasy to aprepitant or excipients * condition that might interfere with drug absorption, distribution metabolism or excretion. * history or current abuse of drugs, alcohol or solvents * inability to understand the nature and extent of the trial and procedures * participation in a drug trial within 30 days prior to 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
References
Publications (0)
Data not yet available
No reference posted for this study.