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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: Completed Phase 3 study of Unspecified Adult Solid Tumor, Protocol Specific and Nausea and Vomiting, sponsored by Heron Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Complete Response is defined as no emetic episodes and no use of rescue medications
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,428 participants |
| Start Date | 2006-06 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
What the finished NCT00343460 record still lists
NCT00343460 is an interventional study that assigns participants to a tested intervention. Its 1,428 participants enrollment target places it among the larger protocols in the corpus, above the 484-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (195% higher).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for Unspecified Adult Solid Tumor, Protocol Specific
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00343460's enrollment target sits among peer trials
1,428 4th of 83 higher than 80 of 83 other Unspecified Adult Solid Tumor, Protocol Specific trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Unspecified Adult Solid Tumor, Protocol Specific trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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