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NCT01534637 · ClinicalTrials.gov registry record · Phase 2

Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Chemotherapy and Radiation Therapy for Pancreatic Cancer

A Phase 2 study, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 2
Development phase
22
Enrollment target

NCT01534637: Completed Phase 2 study, sponsored by Wake Forest University Health Sciences.

NCT01534637 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01534637, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target

Study Summary

This pilot clinical trial is studying how well aprepitant works in preventing nausea and vomiting in patients undergoing chemotherapy and radiation therapy for pancreatic cancer. Antiemetic drugs, such as aprepitant may help lessen or prevent nausea and vomiting in patients receiving chemotherapy and radiation therapy

Primary Outcome

Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Descriptive statistics (means, standard deviations, frequencies, etc.) will be presented for pretreatment patient characteristics. The rate of grade 3 and 4 nausea will be compared to the cut points during interim and final analyses.

Interventions

  • DRUG fluorouracil
  • DRUG capecitabine
  • DRUG gemcitabine hydrochloride
  • DRUG aprepitant
  • PROCEDURE radiation therapy

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2006-08
Est. Completion 2012-08
Phase Phase 2
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT01534637 record still lists

NCT01534637 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 5 interventions - of which fluorouracil is the first listed.

NCT01534637 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01534637 about?

NCT01534637 is a clinical study titled "Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Chemotherapy and Radiation Therapy for Pancreatic Cancer". This pilot clinical trial is studying how well aprepitant works in preventing nausea and vomiting in patients undergoing chemotherapy and radiation therapy for pancreatic cancer. Antiemetic drugs, such as aprepitant may help lessen or prevent nausea and vomiting in patients receiving chemotherapy an...

What is the current status of trial NCT01534637?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2006-08. Estimated completion is 2012-08.

What interventions are being tested in trial NCT01534637?

The interventions under investigation include: fluorouracil (DRUG), capecitabine (DRUG), gemcitabine hydrochloride (DRUG), aprepitant (DRUG), radiation therapy (PROCEDURE).

Who is sponsoring clinical trial NCT01534637?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01534637's enrollment target sits among peer trials

22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01534637, the US trial registry maintained by the National Library of Medicine. NCT01534637 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.