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APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

NCT00343460 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1428

Last updated 2026-03-02

Study results available
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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.

Conditions

  • Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

APF530

Given subcutanously

DRUG

dexamethasone

Given IV and orally

DRUG

Palonosetron Hydrochloride

Given IV

OTHER

placebo

Given subcutanously or IV

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Principal Investigators

  • John Barr, PhD · Heron Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-09-30
Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00343460 on ClinicalTrials.gov