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NCT00838578 · ClinicalTrials.gov registry record · Phase 1

Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer

A Phase 1 study, sponsored by Kyowa Kirin Co..

Terminated
Registry status
Phase 1
Development phase
65
Enrollment target

NCT00838578: Clinical Trial Phase 1 study, sponsored by Kyowa Kirin Co..

NCT00838578 is a Phase 1 study that was terminated before completion, run by Kyowa Kirin Co.. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00838578, a Phase 1 study, was terminated before completion, sponsored by Kyowa Kirin Co..

TERMINATED
Registry status
Phase 1
Development phase
65 participants
Enrollment target

Study Summary

The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in patients with metastatic colorectal cancer.

Interventions

  • DRUG Irinotecan
  • BIOLOGICAL KRN330

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2009-03
Est. Completion 2012-10
Phase Phase 1
Kyowa Kirin Co.

25 total trials

Why NCT00838578 stopped before completion

NCT00838578 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

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

NCT00838578 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00838578 about?

NCT00838578 is a clinical study titled "Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer". The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in patients with metastatic colorect...

What is the current status of trial NCT00838578?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2009-03. Estimated completion is 2012-10.

What interventions are being tested in trial NCT00838578?

The interventions under investigation include: Irinotecan (DRUG), KRN330 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00838578?

This trial is sponsored by Kyowa Kirin Co., which has 25 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00838578's enrollment target sits among peer trials

65 798th of 2000 higher than 1,193 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 NCT00838578, the US trial registry maintained by the National Library of Medicine. NCT00838578 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.