deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT00425672

ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment

Phase I-II Study of Denileukin Diftitox (ONTAK®) in Patients With Advanced Refractory Breast Cancer

Sponsor: National Cancer Institute (NCI)

Conditions Male Breast Cancer Recurrent Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer
Interventions ONTAK enzyme-linked immunosorbent assay flow cytometry immunohistochemistry staining method laboratory biomarker analysis protein expression analysis
Updated 10 times since 2017 Last updated: Nov 9, 2018 Started: Sep 30, 2005 Primary completion: Apr 30, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00425672, this PHASE1/PHASE2 trial focuses on Male Breast Cancer and Recurrent Breast Cancer and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 10 times since 2005, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Sep 2017 · 7 months · monthly snapshotActive Not Recruiting~Sep 2017 – ~Jun 2018 · 9 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshotActive Not Recruiting~Jan 2019 – ~Jan 2021 · 24 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 23 months · monthly snapshotCompleted

Change History

10 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE1_PHASE2

  5. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE1_PHASE2

▶ Show 5 earlier versions

  1. Jan 2019 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not Recruiting → Completed

  2. Jun 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  3. Sep 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  4. Feb 2017 — Sep 2017 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  5. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    First recorded

Sep 2005

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
  • University of Washington
Data source: University of Washington

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

Study Locations