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AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Participants With Advanced Solid Malignancies

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

Amendment history

The 50 most recent of 67 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Study Status, Study Description

    Re-verified, no change to tracked fields

    v67

  2. Minor

    Completion date: Dec 31, 2025 to Mar 26, 2027

    Study Statusv66

  3. Minor

    3 amendments

    3 re-verifications since 2025-05-05, no change to tracked fields

    v63-v65

  4. Minor

    Completion date: Dec 31, 2024 to Dec 31, 2025

    Study Status, Referencesv62

  5. Notable

    Primary endpoints: 1 to 5

    Eligibility criteria expanded, about 5 words; Secondary endpoints: 1 to 44; Study title revised; and 1 more

    Show all 5 changes in this update
    • Notable Primary endpoints: 1 to 5
      Show what changed
      To assess the pharmacokineticsNumber of theParticipants solidWith doseAbnormal formClinical Laboratory Parameters Reported as TEAEs in Part A and Part B Number of AZD6244Participants With Abnormal Echocardiogram (ECHO) Parameters Reported as TEAEs in Part A and Part B Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Part A and Part B Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A and Part B Nu [...]
    • Minor Eligibility criteria expanded, about 5 words
      Show what changed
      Inclusion Criteria: cancer which is refractory to standard therapies World Health Organization (WHO) performance status 0- to 2 evidence of post-menopausal status or negative pregnancy t [...]
    • Minor Secondary endpoints: 1 to 44
      Show what changed
      ToMaximum assessPlasma safetyConcentration and tolerability of solid dose form(Cmax) of AZD6244 (Part A) Cmax of AZD6244 (Part B Single Dose) Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) of AZD6244 (Part A) Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC[0-12]) of AZD6244 (Part A) AUC of AZD6244 (Part B Single Dose) A [...]
    • Minor Study title revised
      Show what changed
      AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in PatientsParticipants With Advanced Solid Malignancies
    • Minor Study arms: 1 to 6

    Study Identification, Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibilityv61

Show 43 earlier versions
  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v60

  2. Minor

    Completion date: Dec 29, 2023 to Dec 31, 2024

    Study Statusv59

  3. Minor

    3 amendments

    3 re-verifications since 2023-03-20, no change to tracked fields

    v56-v58

  4. Minor

    Completion date: Dec 30, 2022 to Dec 29, 2023

    Study Status, Study Designv55

  5. Minor

    3 amendments

    3 re-verifications since 2022-02-22, no change to tracked fields

    v52-v54

  6. Minor

    Completion date: Dec 31, 2021 to Dec 30, 2022

    Study Statusv51

  7. Minor

    3 amendments

    3 re-verifications since 2021-03-05, no change to tracked fields

    v48-v50

  8. Minor

    Completion date: Dec 31, 2020 to Dec 31, 2021

    Study Statusv47

  9. Minor

    3 amendments

    3 re-verifications since 2020-03-23, no change to tracked fields

    v44-v46

  10. Minor

    Completion date: Dec 31, 2019 to Dec 31, 2020

    Study Statusv43

  11. Minor

    3 amendments

    3 re-verifications since 2019-03-26, no change to tracked fields

    v40-v42

  12. Minor

    Completion date: Dec 31, 2018 to Dec 31, 2019

    Study Statusv39

  13. Minor

    3 amendments

    3 re-verifications since 2018-02-06, no change to tracked fields

    v36-v38

  14. Minor

    Completion date: Dec 29, 2017 to Dec 31, 2018

    Study Statusv35

  15. Minor

    Enrollment target: 64 to 58

    Site details revised at 4 of 4 sites

    Study Status, Study Design, Contacts/Locationsv34

  16. Minor

    Primary completion date: Jun 2008 to Jun 17, 2008

    Completion date: Dec 2017 to Dec 29, 2017; Start date: Mar 2007 to Mar 8, 2007

    Study Statusv33

  17. Minor

    Completion date: Dec 2016 to Dec 2017

    Study Statusv32

  18. Minor

    4 amendments

    4 re-verifications since 2016-02-01, no change to tracked fields

    v28-v31

  19. Minor

    Completion date: Dec 2015 to Dec 2016

    Study Status, Study Designv27

  20. Minor

    Study Status, Eligibility

    Re-verified, no change to tracked fields

    v26

  21. Minor

    Completion date: Mar 2015 to Dec 2015

    Study Statusv25

  22. Minor

    Study Status

    Re-verified, no change to tracked fields

    v24

  23. Minor

    Completion date: Dec 2014 to Mar 2015

    Study Statusv23

  24. Minor

    2 amendments

    2 re-verifications since 2014-07-14, no change to tracked fields

    v21-v22

  25. Minor

    Study sites: 6 to 4

    Study Status, Contacts/Locationsv20

  26. Minor

    Enrollment target: estimated 90 to confirmed 64

    Study sites: 5 to 6; Completion date: Feb 2014 to Dec 2014

    Study Status, Study Design, Contacts/Locations, Referencesv19

  27. Minor

    Completion date: Aug 2013 to Feb 2014

    Study Status, Referencesv18

  • 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.
727 trials monitored
See 63 trials at risk
The primary purpose of the study is to assess the safety, tolerability and pharmacokinetics of a capsule of AZD6244 in participants with advanced solid malignancies
Trial Details
NCT Number NCT00463814
Lead Sponsor AstraZeneca
Conditions Tumor, Cancer
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov