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NCT00398879 · ClinicalTrials.gov registry record · Phase 2

Placebo-Controlled Study of Perifosine + Single Agent Chemotherapy for Metastatic Cancer Patients

A Phase 2 study, sponsored by AEterna Zentaris.

Completed
Registry status
Phase 2
Development phase
381
Enrollment target

NCT00398879: Completed Phase 2 study, sponsored by AEterna Zentaris.

NCT00398879 is a Phase 2 study that has completed, run by AEterna Zentaris. The registered enrollment target is 381 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (186% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00398879, a Phase 2 study, has completed, sponsored by AEterna Zentaris.

COMPLETED
Registry status
Phase 2
Development phase
381 participants
Enrollment target

Study Summary

This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. The study is subsequently closed to enrollment in all arms except patients with metastatic colorectal cancer which would be randomized to either capecitabine plus perifosine or capecitabine alone. The effects of perifosine may be manifested by increased time to progression, tumor regression reflected in partial or complete responses, or a combination of these outcomes. The primary goal of this trial is to obtain a preliminary and objective assessment of the effects of perifosine on time to progression.

Primary Outcome

Time to progression will be measured from the first day of study drug until progression.

Interventions

  • DRUG Capecitabine
  • DRUG Perifosine
  • OTHER Perifosine Placebo

Trial Details

FieldValue
Enrollment Target 381 participants
Start Date 2005-08
Est. Completion 2011-10
Phase Phase 2
AEterna Zentaris

21 total trials

What the finished NCT00398879 record still lists

NCT00398879 is an interventional study that assigns participants to a tested intervention. The registered 381 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (186% higher).

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

NCT00398879 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00398879 about?

NCT00398879 is a clinical study titled "Placebo-Controlled Study of Perifosine + Single Agent Chemotherapy for Metastatic Cancer Patients". This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. The study is subsequently closed to enrollment in all arms except patients with metastatic colorectal cancer which would be randomized to either capecitabine plus perifosine or ...

What is the current status of trial NCT00398879?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 381 participants. The study started on 2005-08. Estimated completion is 2011-10.

What interventions are being tested in trial NCT00398879?

The interventions under investigation include: Capecitabine (DRUG), Perifosine (DRUG), Perifosine Placebo (OTHER).

Who is sponsoring clinical trial NCT00398879?

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 NCT00398879's enrollment target sits among peer trials

381 111th of 2000 higher than 1,890 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 NCT00398879, the US trial registry maintained by the National Library of Medicine. NCT00398879 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.