Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer

StatusSuspended
PhasePhase 1
Started

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Record History

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  1. Recruitment suspended Sponsor's reason: Accrual goal met Show 4 more changesShow less
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description revised
    • Site details revised at 3 of 3 sites
  2. Primary and study completion dates: Feb 28, 2026 to Oct 5, 2027v20
  3. Primary and study completion dates: Oct 4, 2025 to Feb 28, 2026v19
  4. Primary and study completion dates: Apr 30, 2025 to Oct 4, 2025v18
  5. Study sites: 2 to 3v17
Show 15 earlier versionsHide 15 earlier versions
  1. Start date changed from estimate of Jun 20, 2023 to Sep 14, 2020v16
  2. Start date: Mar 20, 2023 to Jun 20, 2023v15
  3. Start date: Feb 20, 2023 to Mar 20, 2023v14
  4. Trial status: Suspended to Recruiting
    • Start date: Jan 25, 2023 to Feb 20, 2023
    • Site details revised at 2 of 2 sites
    v13
  5. Trial status: Recruiting to Suspended Sponsor's reason: Feasibility
    • Start date: Oct 25, 2022 to Jan 25, 2023
    • Site details revised at 2 of 2 sites
    v12
  6. Start date: Sep 4, 2022 to Oct 25, 2022v11
  7. Start date: Jul 4, 2022 to Sep 4, 2022v10
  8. Start date: May 4, 2022 to Jul 4, 2022v9
  9. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 1 to 6
    • Start date: May 4, 2020 to May 4, 2022
    • Site details revised at 2 of 2 sites
    v8
  10. Lead sponsor: Manisha Shah to City of Hope Medical Center
    • Enrollment target: estimated 20 to confirmed 1
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (2)
    v7
  11. Study sites: 1 to 2v6
  12. Primary and study completion dates: Dec 31, 2021 to Apr 30, 2025v5
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2020 to May 4, 2020
    • Site details revised
    v4
  14. Start date: Nov 1, 2019 to May 1, 2020v3
  15. Start date: Aug 1, 2019 to Nov 1, 2019v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 trial studies how well dabrafenib, trametinib, and intensity modulated radiation therapy (IMRT) work together in treating patients with BRAF mutated anaplastic thyroid cancer. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving dabrafenib, trametinib, and IMRT together may kill more tumor cells.
Trial Details
NCT Number NCT03975231
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 BRAF NP_004324.2:p.V600E, BRAF V600K Mutation Present, Thyroid Gland Anaplastic Carcinoma
Related terms Thyroid Carcinoma, Anaplastic
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov