Clinical trial · Interventional
APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
A Pivotal Phase 3 Observer-Blind, Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared to Aloxi For The Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following The Administration of Either Moderately or Highly Emetogenic Chemotherapy Regimens
NCT00343460CI-TRIAL-00104304completedPhase 3Results postedClinicalTrials.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 randomized phase III trial is studying APF530 and dexamethasone to see how well they work compared with palonosetron and dexamethasone in preventing nausea and vomiting in patients receiving chemotherapy for 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 |
|---|---|---|---|
| Nausea and Vomiting | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APF530 | Drug | — | UNRESOLVED |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| Palonosetron Hydrochloride | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients receive palonosetron hydrochloride IV, placebo subcutaneously (SC), and dexamethasone IV on day 1 of chemotherapy course 1. Patients in the high-risk (level 5) stratum also receive oral dexamethasone on days 2-4 of all treatment courses.
- interventionNames
- Drug: dexamethasone
- Drug: Palonosetron Hydrochloride
- Other: placebo
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive APF530 SC, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I.
- interventionNames
- Drug: APF530
- Drug: dexamethasone
- Other: placebo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant disease * No head and neck cancer or upper gastrointestinal cancer * Scheduled to receive a single day of moderately or highly emetogenic chemotherapy regimen (for ≤ 4 courses) * Chemotherapy administration ≤ 4 hours * Duration of each course ≤ 28 days * Causing nausea and vomiting in 30-100% of patients if untreated according to Hesketh algorithm * Must be able to receive standardized doses of dexamethasone for the prevention of emesis during study treatment * No greater than mild nausea or any vomiting within 24 hours before beginning study treatment PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known allergy or hypersensitivity to other selective 5-HT3 receptor antagonists or local anesthetics * QTc interval ≤ 500 ms * No cardiac abnormality predisposing the patient to arrhythmia * No psychological problem that, in the opinion of the investigator, is severe enough to preclude study participation * No recent history (i.e., ≤ 1 year) of alcohol or drug abuse * No concurrent condition that, in the opinion of the investigator, could affect assessment of study medication or interfere with the nausea/vomiting response (e.g., severe renal or hepatic impairment) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No radiotherapy 7 days prior to, during, and 5 days after completion of study treatment * More than 7 days since prior chemotherapy * More than 7 days since prior and no concurrent prohibited medications (e.g., CYP3A4 inhibitors or other antiemetic medications) * More than 7 days since prior antinausea medications * More than 30 days since prior treatment on an investigational trial * No other concurrent corticosteroids or dexamethasone at a different dose than study treatment * No concurrent use of APF530, palonosetron hydrochloride, or aprepitant as rescue medications
References
Publications (2)
- DERIVEDBoccia R, O'Boyle E, Cooper W. Randomized phase III trial of APF530 versus palonosetron in the prevention of chemotherapy-induced nausea and vomiting in a subset of patients with breast cancer receiving moderately or highly emetogenic chemotherapy. BMC Cancer. 2016 Feb 26;16:166. doi: 10.1186/s12885-016-2186-4. PMID 26921245
- DERIVEDRaftopoulos H, Boccia R, Cooper W, O'Boyle E, Gralla RJ. Slow-release granisetron (APF530) versus palonosetron for chemotherapy-induced nausea/vomiting: analysis by American Society of Clinical Oncology emetogenicity criteria. Future Oncol. 2015 Sep;11(18):2541-51. doi: 10.2217/fon.15.185. Epub 2015 Aug 20. PMID 26289588