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NCT00398697 · ClinicalTrials.gov registry record · Phase 1

Phase I Perifosine and Gemcitabine Study

A Phase 1 study, sponsored by AEterna Zentaris.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target

NCT00398697: Completed Phase 1 study, sponsored by AEterna Zentaris.

NCT00398697 is a Phase 1 study that has completed, run by AEterna Zentaris. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00398697, a Phase 1 study, has completed, sponsored by AEterna Zentaris.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target

Study Summary

This is a study of the drug perifosine in combination with Gemcitabine. Perifosine is an oral anti-cancer agent that has been used in more than 140 people, but has not been combined with other drugs before this study. The study is designed to determine the highest dose of perifosine that can be administered to people every day while they are on a Gemcitabine regimen, without severe or prolonged nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day. After the highest tolerable dose is found, we will add 10 more patients at that dose.

Interventions

  • DRUG Gemcitabine
  • DRUG Perifosine

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2004-08
Est. Completion 2006-01
Phase Phase 1
AEterna Zentaris

21 total trials

What the finished NCT00398697 record still lists

NCT00398697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.

NCT00398697 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00398697 about?

NCT00398697 is a clinical study titled "Phase I Perifosine and Gemcitabine Study". This is a study of the drug perifosine in combination with Gemcitabine. Perifosine is an oral anti-cancer agent that has been used in more than 140 people, but has not been combined with other drugs before this study. The study is designed to determine the highest dose of perifosine that can be admi...

What is the current status of trial NCT00398697?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2004-08. Estimated completion is 2006-01.

What interventions are being tested in trial NCT00398697?

The interventions under investigation include: Gemcitabine (DRUG), Perifosine (DRUG).

Who is sponsoring clinical trial NCT00398697?

This trial is sponsored by AEterna Zentaris, which has 21 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00398697's enrollment target sits among peer trials

19 1716th of 2000 higher than 281 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 NCT00398697, the US trial registry maintained by the National Library of Medicine. NCT00398697 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.