Clinical trial · Interventional
Effect of Aprepitant on Cyclophosphamide Pharmacokinetics in Patients With Breast Cancer
Evaluating the Effect of Aprepitant on Cyclophosphamide Pharmacokinetics
NCT00719173CI-TRIAL-00082185NRRcompletedPhase 1ClinicalTrials.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)
RATIONALE: Antiemetic drugs, such as aprepitant, may help lessen or prevent nausea and vomiting in patients undergoing chemotherapy. PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works compared to placebo in preventing nausea and vomiting in patients undergoing chemotherapy for breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aprepitant | Drug | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive aprepitant 125 mg orally once daily on day 1 and 80 mg orally once daily on days 2 and 3. Beginning 1 hour after receiving aprepitant, patients receive an infusion of cyclophosphamide on day 1. During course 2, patients crossover and receive treatment as in arm II.
- interventionNames
- Drug: aprepitant
- Drug: cyclophosphamide
- Other: placebo
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive a placebo 125 mg orally once daily on day 1 and 80 mg orally once daily on days 2 and 3. Beginning 1 hour after receiving the placebo, patients will receive an infusion of cyclophosphamide infusion on day 1. During course 2, patients crossover and receive treatment as in arm I.
- interventionNames
- Drug: aprepitant
- Drug: cyclophosphamide
- Other: placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * Planning to receive cyclophosphamide 600 mg/m²-1,000 mg/m² IV infusion * No cyclophosphamide dose change between courses 1 and 2 PATIENT CHARACTERISTICS: * Life expectancy ≥ 2 months * ANC ≥ 1,500/μL * Platelet count ≥ 100 x 10\^9/L * Hemoglobin ≥ 9.0 g/dL * Serum creatinine ≤ 1.5 mg/dL * AST/ALT ≤ 2 times upper limit of normal * Not pregnant or nursing * No contraindication to aprepitant PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent medications that are CYP3A4 substrates, inhibitors, and/or inducers, with the exception of the dexamethasone contained as part of the standard antiemetic regimen
References
Publications (1)
- DERIVEDWalko CM, Combest AJ, Spasojevic I, Yu AY, Bhushan S, Hull JH, Hoskins J, Armstrong D, Carey L, Collicio F, Dees EC. The effect of aprepitant and race on the pharmacokinetics of cyclophosphamide in breast cancer patients. Cancer Chemother Pharmacol. 2012 May;69(5):1189-96. doi: 10.1007/s00280-011-1815-5. Epub 2012 Jan 15. PMID 22245954