Clinical trial
APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in…
NCT00343460 · Heron Therapeutics, Industry · Completed
Key facts
| NCT number | NCT00343460 |
|---|---|
| Title | APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer |
| Official title | 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 |
| Lead sponsor | Heron Therapeutics, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific |
| Intervention type | Drug, Other |
| Interventions | APF530, dexamethasone, Palonosetron Hydrochloride, placebo |
| Enrollment | 1,428 |
| Start date | Jun 1, 2006 |
| Primary completion | Sep 1, 2008 |
| Completion | Feb 1, 2009 |
| First posted | Jun 23, 2006 |
| Last update posted | Feb 23, 2017 |
| Countries | United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: