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NCT01649258 · ClinicalTrials.gov registry record · Phase 1

Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy

A Phase 1 study, sponsored by University of Southern California.

Terminated
Registry status
Phase 1
Development phase
29
Enrollment target

NCT01649258: Clinical Trial Phase 1 study, sponsored by University of Southern California.

NCT01649258 is a Phase 1 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01649258, a Phase 1 study, was terminated before completion, sponsored by University of Southern California.

TERMINATED
Registry status
Phase 1
Development phase
29 participants
Enrollment target

Study Summary

This clinical trial studies how well fosaprepitant dimeglumine and granisetron transdermal system work in preventing nausea and vomiting in patients with breast cancer undergoing chemotherapy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy

Primary Outcome

The complete response rate with the exact 95% confidence intervals (CIs) will be calculated. The associations between the complete response rate and patient characteristics and biomarkers will be examined using Fisherâs exact test or Mann-Whitney U test whenever appropriate.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG granisetron transdermal system
  • DRUG fosaprepitant dimeglumine

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2012-09-04
Est. Completion 2017-09-30
Phase Phase 1
University of Southern California

617 total trials

Why NCT01649258 stopped before completion

NCT01649258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.

NCT01649258 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01649258 about?

NCT01649258 is a clinical study titled "Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy". This clinical trial studies how well fosaprepitant dimeglumine and granisetron transdermal system work in preventing nausea and vomiting in patients with breast cancer undergoing chemotherapy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy

What is the current status of trial NCT01649258?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2012-09-04. Estimated completion is 2017-09-30.

What interventions are being tested in trial NCT01649258?

The interventions under investigation include: laboratory biomarker analysis (OTHER), granisetron transdermal system (DRUG), fosaprepitant dimeglumine (DRUG).

Who is sponsoring clinical trial NCT01649258?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01649258's enrollment target sits among peer trials

29 1440th of 2000 higher than 554 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 NCT01649258, the US trial registry maintained by the National Library of Medicine. NCT01649258 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.