deltatrials
Active Not Recruiting PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT02420847

Ixazomib Citrate With Gemcitabine Hydrochloride and Doxorubicin Hydrochloride in Treating Patients With Urothelial Cancer That is Metastatic or Cannot Be Removed by Surgery

A Phase I Two-Dimensional Dose-Finding Study of Ixazomib in Combination With Gemcitabine and Doxorubicin, Followed by a Phase II Extension to Assess the Efficacy of This Combination in Metastatic, Surgically Unresectable Urothelial Cancer

Sponsor: M.D. Anderson Cancer Center

Conditions Metastatic Urothelial Carcinoma Transitional Cell Carcinoma Unresectable Transitional Cell Carcinoma
Interventions Doxorubicin Hydrochloride Gemcitabine Hydrochloride Ixazomib Citrate
Updated 21 times since 2017 Last updated: Nov 6, 2025 Started: Jul 3, 2015 Primary completion: Dec 31, 2025 Completion: Dec 31, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Metastatic Urothelial Carcinoma and Transitional Cell Carcinoma and is currently ongoing. M.D. Anderson Cancer Center leads this study, which shows 21 recorded versions since 2015 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Oct 2017 · 8 months · monthly snapshot~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Jun 2019 · 10 months · monthly snapshot~Jun 2019 – ~Dec 2019 · 6 months · monthly snapshot~Dec 2019 – ~Apr 2020 · 4 months · monthly snapshot~Apr 2020 – ~Aug 2020 · 4 months · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Feb 2022 · 13 months · monthly snapshot~Feb 2022 – ~Sep 2022 · 7 months · monthly snapshot~Sep 2022 – ~Sep 2023 · 12 months · monthly snapshot~Sep 2023 – ~Mar 2024 · 6 months · monthly snapshot~Mar 2024 – ~Jun 2024 · 3 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Jun 2025 · 5 months · monthly snapshot~Jun 2025 – ~Dec 2025 · 6 months · monthly snapshot~Dec 2025 – present · 7 months · monthly snapshot

Change History

21 versions recorded

  1. Dec 2025 — Present [monthly]

    Active Not Recruiting PHASE1/PHASE2

  2. Jun 2025 — Dec 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  3. Jan 2025 — Jun 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  4. Sep 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

▶ Show 16 earlier versions

  1. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  2. Mar 2024 — Jun 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  3. Sep 2023 — Mar 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  4. Sep 2022 — Sep 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  5. Feb 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  6. Jan 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  7. Aug 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  8. Apr 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  9. Dec 2019 — Apr 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  10. Jun 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  11. Aug 2018 — Jun 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  12. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE1_PHASE2

  13. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE1_PHASE2

  14. Oct 2017 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  15. Feb 2017 — Oct 2017 [monthly]

    Recruiting PHASE1_PHASE2

  16. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Jul 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: M.D. Anderson Cancer Center

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

Study Locations