At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,428 enrolled
Drug / intervention
APF530 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating APF530, dexamethasone, and 2 other interventions for Nausea and Vomiting and Unspecified Adult Solid Tumor, Protocol Specific. Completed, enrolled 1,428 participants across 52 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2006
First PostedJun 2006
Primary CompletionSep 2008
Study CompletionFeb 2009
TodayJul 2026
First PostedJun 23, 2006
Enrollment StartJun 1, 2006
Primary CompletionSep 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.0 years ago
Interventions
APF530drug
Given subcutanously
dexamethasonedrug
Given IV and orally
Palonosetron Hydrochloridedrug
Given IV
placeboother
Given subcutanously or IV