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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 is a Phase 2 study that has completed, run by AEterna Zentaris. The registered enrollment target is 381 participants.

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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.

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

Sponsor

AEterna Zentaris

21 total trials

What the Registry Record Tells You About NCT00398879

The ClinicalTrials.gov registry entry for NCT00398879 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 381 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AEterna Zentaris, which has 21 total studies on file at ClinicalTrials.gov.

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

NCT00398879 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.