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DS-3201b in Participants With Lymphomas

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Dec 31, 2026 to Dec 31, 2027v29
  2. Completion date: Dec 31, 2024 to Dec 31, 2026v28
  3. Interventions: DS-3201b (Drug) to DS-3201b (Drug), DS-3201b (Drug) Secondary endpoints: 8 to 6 · Study arms: 1 to 2v27 Show 2 more changesShow less
    • Secondary endpoints: 8 to 6
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  4. Site details revised at 5 of 20 sitesv26
  5. Completion date: Dec 31, 2023 to Dec 31, 2024v25
Show 23 earlier versionsHide 23 earlier versions
  1. Completion date: Dec 31, 2024 to Dec 31, 2023v24
  2. Re-verified, no change to tracked fieldsv23
  3. Primary completion date: Aug 31, 2022 to Dec 31, 2022v22
  4. Primary completion date: Jul 31, 2022 to Aug 31, 2022v21
  5. Completion date: Jul 31, 2024 to Dec 31, 2024 Start date: Mar 2016 to Mar 31, 2016v20 Show 1 more changeShow less
    • Start date: Mar 2016 to Mar 31, 2016
  6. Trial status: Recruiting to Active, Not Recruiting Site details revised at 20 of 20 sitesv19 Show 1 more changeShow less
    • Site details revised at 20 of 20 sites
  7. Study sites revised (20)v18 See this version in full on ClinicalTrials.gov ↗
  8. Primary completion date: Sep 2021 to Jul 31, 2022 Primary endpoints: 14 to 12 · Study sites: 18 to 20 · Completion date: Sep 2021 to Jul 31, 2024 · 2 morev17 Show 5 more changesShow less
    • Primary endpoints: 14 to 12
    • Study sites: 18 to 20
    • Completion date: Sep 2021 to Jul 31, 2024
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 5 to 8

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 17 to 18v16
  10. Study sites: 15 to 17v15
  11. Primary completion date: Oct 2020 to Sep 2021 Primary endpoints: 10 to 14 · Enrollment target: 70 to 100 · Completion date: May 2021 to Sep 2021 · 2 morev14 Show 5 more changesShow less
    • Primary endpoints: 10 to 14
    • Enrollment target: 70 to 100
    • Completion date: May 2021 to Sep 2021
    • Eligibility criteria expanded, about 36 words
    • Site details revised at 14 of 15 sites

    See this version in full on ClinicalTrials.gov ↗

  12. Re-verified, no change to tracked fieldsv13
  13. Study sites: 14 to 15v12
  14. Enrollment target: 50 to 70 Study sites: 12 to 14 · Completion date: Jan 2021 to May 2021 · Eligibility criteria expanded, about 20 words · 1 morev11 Show 4 more changesShow less
    • Study sites: 12 to 14
    • Completion date: Jan 2021 to May 2021
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: 3 to 5

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 10 to 12v10
  16. Primary completion date: Mar 2019 to Oct 2020 Enrollment target: 45 to 50 · Study sites: 1 to 10 · Eligibility criteria expanded, about 15 wordsv9 Show 3 more changesShow less
    • Enrollment target: 45 to 50
    • Study sites: 1 to 10
    • Eligibility criteria expanded, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  17. Re-verified, no change to tracked fieldsv8
  18. Primary endpoints: 5 to 10 Enrollment target: 36 to 45 · Completion date: Apr 2019 to Jan 2021 · Eligibility criteria shortened, about 227 words · 3 morev7 Show 6 more changesShow less
    • Enrollment target: 36 to 45
    • Completion date: Apr 2019 to Jan 2021
    • Eligibility criteria shortened, about 227 words
    • Secondary endpoints revised (3)
    • Study title shortened, about 9 words
    • Collaborators expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  19. Primary completion date: Mar 2018 to Mar 2019 Completion date: Apr 2018 to Apr 2019v6 Show 1 more changeShow less
    • Completion date: Apr 2018 to Apr 2019
  20. 4 versions Re-verified since Oct 6, 2016, no change to tracked fieldsv2-v5
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
DS-3201b is an experimental drug that is being investigated in clinical research. Adults with non-Hodgkin lymphoma (NHL) may be able to join this study if their disease has come back after remission or is not responding to current treatment This study has three parts. The Dose Escalation part is designed is to find the safe dose of DS-3201b that adults with advanced NHL can tolerate. The Dose Expansion phase will determine how effective DS-3201b is for rare types of NH and collect additional safety data. Last, the Drug-Drug Interaction (DDI) Cohort (US Only) will evaluate the effect of DS-3201b on the pharmacokinetics (PK) of midazolam and digoxin when co-administered to patients with NHL
Trial Details
NCT Number NCT02732275
Lead Sponsor Daiichi Sankyo Co., Ltd.
Collaborators: Daiichi Sankyo
Conditions Lymphoma, Malignant, Non-hodgkin Lymphoma
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov