Clinical trial · Interventional
Fosrolapitant and Palonosetron for the Prevention of Antibody-drug Conjugate-induced Nausea and Vomiting
A Randomized Controlled Study of Fosrolapitant and Palonosetron for the Prevention of Nausea and Vomiting Induced by Antibody-Drug Conjugates in Cancer Patients
NCT07692451CI-TRIAL-00117361not yet recruitingPhase 2ClinicalTrials.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)
This study is aimed to evaluate the efficacy and safety of Fosrolapitant and Palonosetron for Antibody-drug conjugate-induced nausea and vomiting
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 |
|---|---|---|---|
| Nausea and Vomiting Induced by Antibody-drug Conjugates (ADCs) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fosrolapitant and Palonosetron for injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fosrolapitant and Palonosetron + dexamethasone + placebo
- description
- Use this field to provide additional information about the arm, including a description of the intervention(s) administered.
- interventionNames
- Drug: Fosrolapitant and Palonosetron for injection
- type
- ACTIVE_COMPARATOR
- label
- fosaprepitant dimeglumine for injection+palonosetron hydrochloride injection+dexamethasone
- description
- Use this field to provide additional information about the arm, including a description of the intervention(s) administered.
- interventionNames
- Drug: Fosrolapitant and Palonosetron for injection
Primary outcomes (1)
- measure
- Complete response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Exclusion Criteria: 1. 18 years of age or older, of either gender 2. Has a diagnosed malignant tumor 3. has never been treated with ADCs and is to receive the first course of ADCs 4. Predicted life expectancy of ≥ 3 months 5. Has a performance status (ECOG scale) of 0 to 1 6. Adequate bone marrow, kidney, and liver function 7. Women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment 8. Able and willing to provide a written informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.