deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT03028103

Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients

An Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize the Effects of a Moderate CYP3A Inhibitor on the Pharmacokinetics of Tazemetostat (EPZ-6438) (Part A), the Effects of Tazemetostat on the Pharmacokinetics of CYP2C8 and CYP2C19 Substrates, and the Effect of Increased Gastric pH on the Pharmacokinetics of Tazemetostat (Part B) in Subjects With B-cell Lymphoma or Advanced Solid Tumors

Sponsor: Epizyme, Inc.

Conditions Advanced Solid Tumor Diffuse Large B Cell Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma Primary Mediastinal Lymphoma
Interventions Fluconazole Omeprazole Repaglinide Tazemetostat
Updated 16 times since 2017 Last updated: Jun 23, 2023 Started: Mar 27, 2017 Primary completion: Oct 31, 2019 Completion: Nov 29, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03028103, this PHASE1 trial focuses on Advanced Solid Tumor and Diffuse Large B Cell Lymphoma and remains completed. Sponsored by Epizyme, Inc., it has been updated 16 times since 2017, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshot~Jul 2017 – ~Dec 2017 · 5 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Dec 2018 · 4 months · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~Aug 2019 · 5 months · monthly snapshot~Aug 2019 – ~Jan 2021 · 17 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Dec 2022 · 19 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2023 · 6 months · monthly snapshot~Jul 2023 – ~Jul 2024 · 12 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

16 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jul 2023 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jan 2023 — Jul 2023 [monthly]

    Completed PHASE1

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE1

▶ Show 11 earlier versions

  1. May 2021 — Dec 2022 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  2. Jan 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE1

  3. Aug 2019 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

  4. Mar 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  5. Jan 2019 — Mar 2019 [monthly]

    Recruiting PHASE1

  6. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE1

    Status: Active Not Recruiting → Recruiting

  7. Aug 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE1

  8. Jun 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  9. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE1

  10. Jul 2017 — Dec 2017 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  11. Feb 2017 — Jul 2017 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Epizyme, Inc.
Data source: Ipsen

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

Study Locations