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Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

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

Record History

  1. Minor Collaborators revised (3)
  2. Notable Sponsor changed: Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair to Medicine Invention Design, Inc Primary endpoints: details revised at 2 of 2 entries · Eligibility criteria expanded, about 29 words · Study description expanded, about 8 words · 1 more Show 4 more changesShow less
    • Primary endpoints: details revised at 2 of 2 entries
    • Eligibility criteria expanded, about 29 words
    • Study description expanded, about 8 words
    • Collaborators: 2 to 3
  3. Notable Sponsor changed: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair to Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair Trial arms changed: 2 → 1 · Interventions: Alectinib (Drug) to ALECENSA - alectinib hydrochloride capsule (Drug) · Eligibility criteria shortened, about 10 wordsv25 Show 3 more changesShow less
    • Trial arms changed: 2 → 1
    • Interventions: Alectinib (Drug) to ALECENSA - alectinib hydrochloride capsule (Drug)
    • Eligibility criteria shortened, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  4. Notable Lead sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair to Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair Interventions: Alectinib - Study (Drug), Alectinib - Usual (Drug) to Alectinib (Drug) · Study arms: 2 to 1 · Eligibility criteria shortened, about 4 words · 1 morev24 Show 4 more changesShow less
    • Interventions: Alectinib - Study (Drug), Alectinib - Usual (Drug) to Alectinib (Drug)
    • Study arms: 2 to 1
    • Eligibility criteria shortened, about 4 words
    • Study description shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Minor Re-verified, no change to tracked fieldsv23
  6. Minor Study title shortened, about 1 wordv22 See this version in full on ClinicalTrials.gov ↗
  7. Notable Primary endpoint(s) modified Eligibility criteria expanded, about 2 words · Study description expanded, about 2 wordsv21 Show 2 more changesShow less
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  8. Notable Primary endpoints: 3 to 2 Eligibility criteria expanded, about 41 wordsv20 Show 1 more changeShow less
    • Eligibility criteria expanded, about 41 words

    See this version in full on ClinicalTrials.gov ↗

  9. Notable Primary endpoint(s) modified Eligibility criteria expanded, about 9 wordsv19 Show 1 more changeShow less
    • Eligibility criteria expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  10. Minor Collaborators: 1 to 2v18 See this version in full on ClinicalTrials.gov ↗
  11. Minor Study sites: 1 to 2v17
  12. Minor Study title expanded, about 1 wordv16 See this version in full on ClinicalTrials.gov ↗
  13. Minor Study title shortened, about 1 wordv15 See this version in full on ClinicalTrials.gov ↗
  14. Notable Start date changed from estimate of Nov 8, 2025 to Mar 18, 2026 Trial status: Not Yet Recruiting to Active, Not Recruiting · Study site revised · Study title revisedv14 Show 3 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study site revised
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  15. Notable Primary completion date: Nov 18, 2025 to Nov 18, 2026 Start date: Nov 8, 2024 to Nov 8, 2025 · Completion date: Dec 28, 2025 to Dec 28, 2026v13 Show 2 more changesShow less
    • Start date: Nov 8, 2024 to Nov 8, 2025
    • Completion date: Dec 28, 2025 to Dec 28, 2026
  16. Minor Collaborators expanded, about 1 wordv12 See this version in full on ClinicalTrials.gov ↗
  17. Notable Primary completion date: Nov 18, 2024 to Nov 18, 2025 Start date: Mar 8, 2024 to Nov 8, 2024 · Completion date: Dec 28, 2024 to Dec 28, 2025 · Eligibility criteria shortened, about 10 words · 1 morev11 Show 4 more changesShow less
    • Start date: Mar 8, 2024 to Nov 8, 2024
    • Completion date: Dec 28, 2024 to Dec 28, 2025
    • Eligibility criteria shortened, about 10 words
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  18. Minor Study description revised Eligibility criteria shortened, about 2 wordsv10 Show 1 more changeShow less
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  19. Notable Primary completion date: May 18, 2024 to Nov 18, 2024 Start date: Nov 8, 2023 to Mar 8, 2024 · Completion date: May 28, 2024 to Dec 28, 2024v9 Show 2 more changesShow less
    • Start date: Nov 8, 2023 to Mar 8, 2024
    • Completion date: May 28, 2024 to Dec 28, 2024
  20. Minor Re-verified, no change to tracked fieldsv8
  21. Notable Start date: Sep 8, 2023 to Nov 8, 2023 Trial status: Active, Not Recruiting to Not Yet Recruiting · Study description shortened, about 6 words · Site contact updated · 1 morev7 Show 4 more changesShow less
    • Trial status: Active, Not Recruiting to Not Yet Recruiting
    • Study description shortened, about 6 words
    • Site contact updated
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  22. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting Site contact updatedv6 Show 1 more changeShow less
    • Site contact updated
  23. Minor Re-verified, no change to tracked fieldsv5
  24. Notable Primary endpoint revised Start date: Sep 28, 2023 to Sep 8, 2023 · Interventions: Crizotinib - Study (Drug), Crizotinib - Usual (Drug) to Alectinib - Study (Drug), Alectinib - Usual (Drug) · Study title revised · 2 morev4 Show 5 more changesShow less
    • Start date: Sep 28, 2023 to Sep 8, 2023
    • Interventions: Crizotinib - Study (Drug), Crizotinib - Usual (Drug) to Alectinib - Study (Drug), Alectinib - Usual (Drug)
    • Study title revised
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  25. Minor Re-verified, no change to tracked fieldsv3
  26. Notable Primary endpoint revised Interventions: Alectinib - Study (Drug), Alectinib - Usual (Drug) to Crizotinib - Study (Drug), Crizotinib - Usual (Drug) · Site contact updated · Study title revised · 2 morev2 Show 5 more changesShow less
    • Interventions: Alectinib - Study (Drug), Alectinib - Usual (Drug) to Crizotinib - Study (Drug), Crizotinib - Usual (Drug)
    • Site contact updated
    • Study title revised
    • Eligibility criteria shortened, about 2 words
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  27. Minor 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.
Explore the relationship between drug target ALK gene single nucleotide polymorphisms and ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes. Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and ALECENSA - Alectinib side-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
Trial Details
NCT Number NCT05987956
Lead Sponsor Medicine Invention Design, Inc
Collaborators: UnitedHealthcare, Omnicure Clinical Research, Responsible Party: Individual Sponsor: Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair
Conditions ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov