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Pharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms

Study acronym: Drugs-SNPs
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 103 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Sponsor changed: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair to Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chairv103 See this version in full on ClinicalTrials.gov ↗
  2. Eligibility criteria expanded, about 1 wordv102 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv101
  4. Primary completion date: Nov 18, 2024 to Nov 18, 2026 Start date: Jan 2017 to Jul 16, 2025 · Completion date: Dec 28, 2024 to Dec 28, 2026 · Eligibility criteria revised · 2 morev100 Show 5 more changesShow less
    • Start date: Jan 2017 to Jul 16, 2025
    • Completion date: Dec 28, 2024 to Dec 28, 2026
    • Eligibility criteria revised
    • Study description revised
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Collaborators expanded, about 1 wordv99 See this version in full on ClinicalTrials.gov ↗
Show 45 earlier versionsHide 45 earlier versions
  1. Re-verified, no change to tracked fieldsv98
  2. Primary completion date: Nov 2023 to Nov 18, 2024 Completion date: Dec 2023 to Dec 28, 2024 · Eligibility criteria shortened, about 10 words · Study description shortened, about 10 wordsv97 Show 3 more changesShow less
    • Completion date: Dec 2023 to Dec 28, 2024
    • Eligibility criteria shortened, about 10 words
    • Study description shortened, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study site revisedv96 See this version in full on ClinicalTrials.gov ↗
  4. 2 versions Re-verified since Aug 11, 2023, no change to tracked fieldsv94-v95
  5. Eligibility criteria shortened, about 6 words Study description shortened, about 4 wordsv93 Show 1 more changeShow less
    • Study description shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  6. 3 versions Re-verified since Jun 12, 2023, no change to tracked fieldsv90-v92
  7. Phase: Phase 3 to Phase 2/3 Eligibility criteria expanded, about 1 wordv89 Show 1 more changeShow less
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  8. Re-verified, no change to tracked fieldsv88
  9. Phase: Phase 2 to Phase 3v87
  10. Re-verified, no change to tracked fieldsv86
  11. Phase: Phase 3 to Phase 2 Eligibility criteria revised · Primary endpoint revisedv85 Show 2 more changesShow less
    • Eligibility criteria revised
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  12. 2 versions Re-verified since Jan 8, 2023, no change to tracked fieldsv83-v84
  13. Study title shortened, about 1 wordv82 See this version in full on ClinicalTrials.gov ↗
  14. Study title expanded, about 1 wordv81 See this version in full on ClinicalTrials.gov ↗
  15. Lead sponsor: Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair to Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair Primary completion date: Nov 2022 to Nov 2023 · Completion date: Dec 2022 to Dec 2023 · Site details revised · 4 morev80 Show 7 more changesShow less
    • Primary completion date: Nov 2022 to Nov 2023
    • Completion date: Dec 2022 to Dec 2023
    • Site details revised
    • Eligibility criteria expanded, about 1 word
    • Study description expanded, about 2 words
    • Collaborators shortened, about 3 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  16. Primary completion date: Mar 2022 to Nov 2022 Start date: Aug 2016 to Jan 2017 · Completion date: Aug 2022 to Dec 2022v79 Show 2 more changesShow less
    • Start date: Aug 2016 to Jan 2017
    • Completion date: Aug 2022 to Dec 2022
  17. Primary completion date: Mar 2020 to Mar 2022 Completion date: Aug 2020 to Aug 2022v78 Show 1 more changeShow less
    • Completion date: Aug 2020 to Aug 2022
  18. Eligibility criteria expanded, about 25 words Study title revised · Study description shortened, about 2 wordsv77 Show 2 more changesShow less
    • Study title revised
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  19. 2 versions Re-verified since Dec 21, 2019, no change to tracked fieldsv75-v76
  20. Study sites: 4 to 1 Eligibility criteria expanded, about 9 words · Study title revisedv74 Show 2 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  21. 2 versions Re-verified since Oct 23, 2019, no change to tracked fieldsv72-v73
  22. Study title expanded, about 1 wordv71 See this version in full on ClinicalTrials.gov ↗
  23. Re-verified, no change to tracked fieldsv70
  24. Study title expanded, about 1 wordv69 See this version in full on ClinicalTrials.gov ↗
  25. Study title shortened, about 1 wordv68 See this version in full on ClinicalTrials.gov ↗
  26. Study title expanded, about 1 wordv67 See this version in full on ClinicalTrials.gov ↗
  27. Re-verified, no change to tracked fieldsv66
  28. Study sites revised (4) Study title shortened, about 1 wordv65 Show 1 more changeShow less
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  29. Collaborators expanded, about 3 wordsv64 See this version in full on ClinicalTrials.gov ↗
  30. Study description shortened, about 4 wordsv63 See this version in full on ClinicalTrials.gov ↗
  31. Primary completion date: Mar 2018 to Mar 2020 Completion date: Aug 2018 to Aug 2020 · Eligibility criteria expanded, about 8 words · Study description expanded, about 10 words · 2 morev62 Show 5 more changesShow less
    • Completion date: Aug 2018 to Aug 2020
    • Eligibility criteria expanded, about 8 words
    • Study description expanded, about 10 words
    • Study sites revised (4)
    • Publications shortened, about 93 words

    See this version in full on ClinicalTrials.gov ↗

  32. Lead sponsor: Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB Chair to Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chairv61
  33. Study description shortened, about 7 wordsv60 See this version in full on ClinicalTrials.gov ↗
  34. Enrollment target: 800 to 600 Eligibility criteria shortened, about 35 words · Study description shortened, about 222 words · Study title revisedv59 Show 3 more changesShow less
    • Eligibility criteria shortened, about 35 words
    • Study description shortened, about 222 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  35. 2 versions Re-verified since Mar 1, 2017, no change to tracked fieldsv57-v58
  36. Interventions: CARBOPLATIN INJECTION (Drug), CISPLATIN INJECTION (Drug), ETOPOSIDE INJECTION (Drug) to ETOPOSIDE - Study (Drug), ETOPOSIDE - Usual (Drug) Study arms: 3 to 2v56 Show 1 more changeShow less
    • Study arms: 3 to 2
  37. Re-verified, no change to tracked fieldsv55
  38. Phase: Phase 4 to Phase 3 Interventions: CISPLATIN INJECTION (Drug), ETOPOSIDE INJECTION (Drug) to CARBOPLATIN INJECTION (Drug), CISPLATIN INJECTION (Drug), ETOPOSIDE INJECTION (Drug) · Eligibility criteria expanded, about 8 words · Study description expanded, about 15 words · 1 morev54 Show 4 more changesShow less
    • Interventions: CISPLATIN INJECTION (Drug), ETOPOSIDE INJECTION (Drug) to CARBOPLATIN INJECTION (Drug), CISPLATIN INJECTION (Drug), ETOPOSIDE INJECTION (Drug)
    • Eligibility criteria expanded, about 8 words
    • Study description expanded, about 15 words
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  • 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.
Explore the relationship between drug target topoisomerase II gene single nucleotide polymorphisms and Etoposide (VP-16) therapeutic-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes. Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and Etoposide (VP-16) side-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
Trial Details
NCT Number NCT01064466
Lead Sponsor Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair
Collaborators: UnitedHealthcare
Conditions Small Cell Lung Cancer
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov