deltatrials
Terminated PHASE2 INTERVENTIONAL 1-arm NCT00493857

Study of Nimotuzumab and Irinotecan in Metastatic Colorectal Cancer

A Phase II Open-Label, 2-Cohort Study of Nimotuzumab 400 mg Weekly Plus Irinotecan (Cohort 1) and Nimotuzumab 400 mg Every 2 Weeks Plus Irinotecan (Cohort 2) in Patients With Irinotecan-Refractory Metastatic Colorectal Cancer

Sponsor: YM BioSciences

Updated 7 times since 2017 Last updated: Nov 14, 2008 Started: Jun 30, 2007 Primary completion: Aug 31, 2008 Completion: Dec 31, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Cohort 2 not going forward. Manadate changes in Company

This PHASE2 trial investigates Colorectal Cancer and is currently terminated or withdrawn. YM BioSciences leads this study, which shows 7 recorded versions since 2007 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

The patient will receive nimotuzumab every 2 weeks plus irinotecan. Nimotuzumab will be given at a dose of 400 mg once every 2 weeks for 12 weeks. Irinotecan will be given at the same dose and schedule as the last dose and schedule given during the most recent pre-study irinotecan containing therapy. If the tumour does not show signs of further growth after 12 weeks of treatment, the patient will continue receiving nimotuzumab 400 mg every 2 weeks for up to 18 months or as long as they are getting a benefit from the drug.

The patient will receive nimotuzumab every 2 weeks plus irinotecan. Nimotuzumab will be given at a dose of 400 mg once every 2 weeks for 12 weeks. Irinotecan will be given at the same dose and schedule as the last dose and schedule given during the most recent pre-study irinotecan containing therapy. If the tumour does not show signs of further growth after 12 weeks of treatment, the patient will continue receiving nimotuzumab 400 mg every 2 weeks for up to 18 months or as long as they are getting a benefit from the drug.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 7 months · monthly snapshotTerminated~Jan 2026 – present · 3 months · monthly snapshotTerminated

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated PHASE2

  2. Sep 2025 — Present [monthly]

    Terminated PHASE2

  3. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  5. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE2

Show 2 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE2

  2. Jan 2017 — Jun 2018 [monthly]

    Terminated PHASE2

    First recorded

Jun 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • YM BioSciences
Data source: YM BioSciences

For direct contact, visit the study record on ClinicalTrials.gov .