Clinical trial · Interventional
Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy
Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting
NCT01031953CI-TRIAL-00027460terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Drug contract timelines and inadequate enrollment
Summary
Brief summary (as posted)
RATIONALE: Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: This clinical trial is studying the side effects of fosaprepitant dimeglumine and to see how well it works in treating patients with nausea and vomiting caused by chemotherapy.
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 |
|---|---|---|---|
| Breakthrough Nausea and Vomiting | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fosaprepitant dimeglumine | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| survey administration | Other | — | UNRESOLVED |
| systemic chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fosaprepitant
- interventionNames
- Drug: fosaprepitant dimeglumine
- Drug: systemic chemotherapy
- Other: survey administration
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale
- timeFrame
- Baseline to 2 hours after study drug administered.
- description
- The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 2 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 2 hours from baseline would be considered in this outcome measure.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of cancer * Scheduled to receive inpatient chemotherapy containing at least moderately emetogenic agents * May be given for adjuvant, neoadjuvant, curative, or palliative intent * May be given orally, IV, or by continuous infusion on ≥ 1 day * Scheduled to receive 5-HT3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, palonosetron, dolasetron mesylate, or dexamethasone with or without a benzodiazepine) on the day of chemotherapy * Self-report of at least mild nausea (for which the patient feels needs rescuing) or moderate nausea (a score of ≥ 2 on a 4-point Likert scale) OR has had ≥ 1 episode of emesis since receiving chemotherapy * No history of chronic nausea and/or vomiting (without chemotherapy), anticipatory nausea and/or vomiting, or emesis within 24 hours before chemotherapy * No symptomatic brain metastases PATIENT CHARACTERISTICS: * Able to understand English * Not pregnant or nursing * Negative pregnancy test * No clinical evidence of current or impending bowel obstruction (i.e., tumor pressing on the bowel) * No allergy or intolerance to study drugs PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior chemotherapy allowed * No aprepitant as prophylaxis or rescue treatment during the current course of chemotherapy (other than as a part of study therapy) * Not scheduled to receive a dopamine antagonist after chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.