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COMPLETED Phase 3

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

NCT00343460 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • OTHER placebo
  • DRUG dexamethasone
  • DRUG APF530
  • DRUG Palonosetron Hydrochloride

Study Locations (20)

California

  • Pacific Cancer Medical Center, Incorporated — Anaheim
  • Southbay Oncology / Hematology Medical Group — Campbell
  • Compassionate Cancer Care Medical Group Incorporated - Corona — Corona
  • Compassionate Cancer Care Medical Group Incorporated - Fountain Valley — Fountain Valley
  • Advanced Research Management Services, Incorporated — Los Angeles
  • Kenmar Research Institute — Los Angeles
  • Medical Oncology Care Associates - Orange — Orange

Indiana

  • Investigative Clinical Research, LLC — Indianapolis
  • Cancer Center of Indiana — New Albany
  • Family Medicine of Vincennes Clinical Trial Center — Vincennes

Arizona

  • Palo Verde Hematology Oncology - Glendale — Glendale
  • Arizona Clinical Research Center, Incorporated — Tucson

Florida

  • Pasco Pinellas Cancer Center - New Port Richey — New Port Richey
  • Innovative Medical Research of South Florida, Incorporated — North Miami Beach

Alabama

  • Anniston Oncology, PC — Anniston

Arkansas

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences — Little Rock

Connecticut

  • Eastern Connecticut Hematology and Oncology Associates — Norwich

District of Columbia

  • Providence Hospital — Washington D.C.

Trial Details

FieldValue
Enrollment Target 1,428 participants
Start Date 2006-06
Est. Completion 2009-02
Phase Phase 3

Sponsor

Heron Therapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00343460

The ClinicalTrials.gov registry entry for NCT00343460 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,428 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Heron Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Unspecified Adult Solid Tumor, Protocol Specific appearing as the primary indexed condition, and to 4 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00343460 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Indiana, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00343460 about?

NCT00343460 is a clinical study titled "APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer". 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.

What is the current status of trial NCT00343460?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,428 participants. The study started on 2006-06. Estimated completion is 2009-02.

What conditions does trial NCT00343460 study?

This clinical trial studies the following conditions: Unspecified Adult Solid Tumor, Protocol Specific, Nausea and Vomiting. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00343460?

The interventions under investigation include: placebo (OTHER), dexamethasone (DRUG), APF530 (DRUG), Palonosetron Hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00343460?

This trial is sponsored by Heron Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00343460 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial