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NCT00412425 · ClinicalTrials.gov registry record · Phase 1

Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT00412425: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT00412425 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00412425, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

Primary Objectives: * Safety of palonosetron administered for control of nausea and vomiting in patients with metastatic melanoma receiving biochemotherapy. * To determine the patterns and severity of nausea and vomiting in two groups of patients with metastatic melanoma receiving biochemotherapy with palonosetron premedication using two schedules of palonosetron administration.

Primary Outcome

Participants response measured as incidences biochemotherapy emesis and those of nausea interfering with appetite, sleep, physical activity, social life and enjoyment of life are summarized. Response evaluated during 5-day administration of biochemotherapy and the 23 subsequent days after therapy ends.

Interventions

  • DRUG Palonosetron

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2006-11
Est. Completion 2009-05
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00412425 record still lists

NCT00412425 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 1 intervention - of which Palonosetron is the first listed.

NCT00412425 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00412425 about?

NCT00412425 is a clinical study titled "Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting". Primary Objectives: * Safety of palonosetron administered for control of nausea and vomiting in patients with metastatic melanoma receiving biochemotherapy. * To determine the patterns and severity of nausea and vomiting in two groups of patients with metastatic melanoma receiving biochemotherapy w...

What is the current status of trial NCT00412425?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2006-11. Estimated completion is 2009-05.

What interventions are being tested in trial NCT00412425?

The interventions under investigation include: Palonosetron (DRUG).

Who is sponsoring clinical trial NCT00412425?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00412425's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00412425, the US trial registry maintained by the National Library of Medicine. NCT00412425 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.