A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

The 50 most recent of 78 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary completion moved earlier from Mar 31, 2028 to Mar 31, 2027
    • Study completion moved earlier from Apr 30, 2028 to Apr 30, 2027
  2. Primary completion pushed from Dec 31, 2027 to Mar 31, 2028
    • Study completion pushed from Dec 31, 2027 to Apr 30, 2028
    v77
  3. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2027v76
  4. Primary and study completion dates: Apr 30, 2025 to Dec 31, 2025v75
  5. Study sites revised (8)v74
Show 45 earlier versionsHide 45 earlier versions
  1. Start date: Oct 28, 2019 to Nov 4, 2019v73
  2. Primary and study completion dates: Oct 31, 2024 to Apr 30, 2025v72
  3. Primary completion date: Mar 29, 2024 to Oct 31, 2024v71
  4. Study completion date: Mar 29, 2024 to Oct 31, 2024v70
  5. Primary and study completion dates: Sep 29, 2023 to Mar 29, 2024v69
  6. 5 versions Re-verified since Mar 22, 2023, no change to tracked fieldsv64-v68
  7. Primary and study completion dates: Feb 28, 2023 to Sep 29, 2023v63
  8. 3 versions Re-verified since Nov 14, 2022, no change to tracked fieldsv60-v62
  9. Primary and study completion dates: Sep 30, 2022 to Feb 28, 2023v59
  10. 8 versions Re-verified since Apr 21, 2022, no change to tracked fieldsv51-v58
  11. Primary and study completion dates: May 31, 2022 to Sep 30, 2022v50
  12. Primary completion date: Mar 15, 2022 to May 31, 2022
    • Study completion date: Mar 31, 2022 to May 31, 2022
    v49
  13. Re-verified, no change to tracked fieldsv48
  14. Primary completion date: Jan 26, 2022 to Mar 15, 2022v47
  15. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 80 to confirmed 71
    • Site details revised at 8 of 8 sites
    v46
  16. Re-verified, no change to tracked fieldsv45
  17. Study sites: 9 to 8v44
  18. Study sites: 3 to 9v43
  19. Study sites: 8 to 3v42
  20. Re-verified, no change to tracked fieldsv41
  21. Primary completion date: Aug 31, 2021 to Jan 26, 2022v40
  22. Re-verified, no change to tracked fieldsv39
  23. Primary completion date: Jul 23, 2021 to Aug 31, 2021v38
  24. Site contacts updated at 1 of 8 sitesv37
  25. Enrollment target: 140 to 80
    • Study completion date: Feb 15, 2023 to Mar 31, 2022
    v36
  26. Primary completion date: Jun 17, 2021 to Jul 23, 2021v35
  27. 3 versions Re-verified since Apr 9, 2021, no change to tracked fieldsv32-v34
  28. Study Status, Contacts/Locationsv31
  29. 2 versions Re-verified since Mar 15, 2021, no change to tracked fieldsv29-v30
  • 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.
This is a study in adults with advanced cancer (solid tumours) in whom previous chemotherapy was not successful. Only people who have a tumour with a KRAS mutation can participate in the study. A KRAS mutation makes cancer grow faster. The study tests 2 medicines called BI 1701963 and trametinib. BI 1701963 prevents reactivation of KRAS. In this study, BI 1701963 is given to humans for the first time. Trametinib is an approved medicine (MEK inhibitor). The purpose of this study is to find out the highest dose of BI 1701963 alone and in combination with trametinib the participants can tolerate. Another purpose is to check whether BI 1701963 in combination with trametinib is able to make tumours shrink. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they get tablets of BI 1701963 and trametinib once daily. The doctors regularly monitor the size of the tumour. Doctors also regularly record any unwanted effects and check participants' health.
Trial Details
NCT Number NCT04111458
Lead Sponsor Boehringer Ingelheim
Conditions
(from sponsor)		 Solid Tumors, KRAS Mutation; SOS1
Enrollment 71 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov