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NCT00343460 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Nausea and Vomiting, sponsored by Heron Therapeutics.

Completed
Registry status
Phase 3
Development phase
1,428
Enrollment target
20
Study locations

NCT00343460 is a Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Nausea and Vomiting that has completed, run by Heron Therapeutics. The registered enrollment target is 1,428 participants, above the 484-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (195% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT00343460, a Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Nausea and Vomiting, has completed, sponsored by Heron Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
1,428 participants
Enrollment target
20
Study locations

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

23 total trials

What the Registry Record Tells You About NCT00343460

The ClinicalTrials.gov registry entry for NCT00343460 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,428 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 484-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (195% higher). The listed sponsor is Heron Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.

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.

NCT00343460 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Indiana, Arizona.

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.

What interventions are being tested in trial NCT00343460?

The interventions under investigation include: placebo (OTHER), dexamethasone (DRUG), APF530 (DRUG), Palonosetron Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00343460?

This trial is sponsored by Heron Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.