deltatrials
Completed PHASE1 INTERVENTIONAL 5-arm NCT01597193

Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer

A PHASE 1 OPEN-LABEL, DOSE ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ENZALUTAMIDE (FORMERLY MDV3100) IN PATIENTS WITH INCURABLE BREAST CANCER

Sponsor: Astellas Pharma Inc

Conditions Breast Cancer
Interventions anastrozole enzalutamide exemestane fulvestrant
Updated 15 times since 2017 Last updated: May 7, 2019 Started: Apr 30, 2012 Primary completion: Dec 15, 2015 Completion: Jan 22, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01597193, this PHASE1 trial focuses on Breast Cancer and remains completed. Sponsored by Astellas Pharma Inc, it has been updated 15 times since 2012, 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 snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~Feb 2018 · 6 months · monthly snapshot~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~Jun 2019 · 7 months · monthly snapshot~Jun 2019 – ~Sep 2020 · 15 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

15 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE1

  5. Sep 2020 — Jan 2021 [monthly]

    Completed PHASE1

▶ Show 10 earlier versions

  1. Jun 2019 — Sep 2020 [monthly]

    Completed PHASE1

  2. Nov 2018 — Jun 2019 [monthly]

    Completed PHASE1

  3. Jun 2018 — Nov 2018 [monthly]

    Completed PHASE1

  4. May 2018 — Jun 2018 [monthly]

    Completed PHASE1

  5. Apr 2018 — May 2018 [monthly]

    Completed PHASE1

  6. Mar 2018 — Apr 2018 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  7. Feb 2018 — Mar 2018 [monthly]

    Active Not Recruiting PHASE1

  8. Aug 2017 — Feb 2018 [monthly]

    Active Not Recruiting PHASE1

  9. Feb 2017 — Aug 2017 [monthly]

    Active Not Recruiting PHASE1

  10. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE1

    First recorded

Apr 2012

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Astellas Pharma Inc
  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
  • Pfizer
Data source: Pfizer

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

Study Locations