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NCT00048126 · ClinicalTrials.gov registry record · Phase 2

A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

A Phase 2 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
57
Enrollment target

NCT00048126: Completed Phase 2 study, sponsored by Hoffmann-La Roche.

NCT00048126 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00048126, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
57 participants
Enrollment target

Study Summary

This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.

Interventions

  • DRUG Irinotecan
  • DRUG capecitabine [Xeloda]

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2001-07
Est. Completion 2005-01
Phase Phase 2
Hoffmann-La Roche

909 total trials

What the finished NCT00048126 record still lists

NCT00048126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).

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

NCT00048126 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00048126 about?

NCT00048126 is a clinical study titled "A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer". This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample siz...

What is the current status of trial NCT00048126?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2001-07. Estimated completion is 2005-01.

What interventions are being tested in trial NCT00048126?

The interventions under investigation include: Irinotecan (DRUG), capecitabine [Xeloda] (DRUG).

Who is sponsoring clinical trial NCT00048126?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00048126's enrollment target sits among peer trials

57 1141st of 2000 higher than 855 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 NCT00048126, the US trial registry maintained by the National Library of Medicine. NCT00048126 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.