Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04117945 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer

StatusUnknown
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Results first posted: Sep 27, 2024v34
  3. Study sites: 16 to 15
    • Secondary endpoints revised (6)
    v33
  4. Primary completion date changed from estimate of Feb 28, 2024 to Sep 5, 2023
    • Secondary endpoints revised (6)
    • Primary endpoint revised
    v32
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 124 to confirmed 22
    • Site details revised at 16 of 16 sites
    v31
Show 29 earlier versionsHide 29 earlier versions
  1. Site details revised at 1 of 16 sitesv30
  2. Site details revised at 1 of 16 sitesv29
  3. Site details revised at 1 of 16 sitesv28
  4. Site details revised at 1 of 16 sitesv27
  5. Site details revised at 2 of 16 sitesv26
  6. Primary completion date: Feb 28, 2023 to Feb 28, 2024v25
  7. Site details revised at 1 of 16 sitesv24
  8. Site contacts updated at 1 of 16 sitesv23
  9. Site details revised at 1 of 16 sitesv22
  10. Site details revised at 1 of 16 sitesv21
  11. Site details revised at 1 of 16 sitesv20
  12. Study sites: 15 to 16v19
  13. Site details revised at 1 of 15 sitesv18
  14. Site details revised at 1 of 15 sitesv17
  15. Site details revised at 2 of 15 sitesv16
  16. Study sites: 14 to 15v15
  17. Site details revised at 1 of 14 sitesv14
  18. Site details revised at 1 of 14 sitesv13
  19. Site details revised at 2 of 14 sitesv12
  20. Site details revised at 1 of 14 sitesv11
  21. Study sites: 15 to 14v10
  22. Site details revised at 1 of 15 sitesv9
  23. Study sites: 14 to 15v8
  24. Re-verified, no change to tracked fieldsv7
  25. Site details revised at 3 of 14 sitesv6
  26. Site contacts updated at 1 of 14 sitesv5
  27. Study sites: 2 to 14v4
  28. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Feb 29, 2020 to Mar 3, 2020
    v3
  29. Start date: Nov 29, 2019 to Feb 29, 2020v2
  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.
This phase II trial how well regorafenib and anti-EGFR therapy (cetuximab or panitumumab) works for the treatment of patients with colorectal cancer that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic). Regorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab or panitumumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The purpose of this research study is to compare the effects, good and/or bad, of taking regorafenib follow by cetuximab or panitumumab, to those that receive cetuximab or panitumumab before regorafenib.
Trial Details
NCT Number NCT04117945
Lead Sponsor Academic and Community Cancer Research United
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 BRAF V600E Negative, KRAS Gene Mutation Negative, Locally Advanced Unresectable Colorectal Adenocarcinoma, Metastatic Colorectal Adenocarcinoma, NRAS Gene Mutation Negative, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8 +5 more
Related terms Colorectal Neoplasms
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov