deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT03317119

Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery

A Phase I Clinical Trial of Trametinib in Combination With TAS-102 in Patients With Chemotherapy-Resistant RAS-Mutated (PIK3CA/PTEN-Wild-Type) Metastatic Colorectal Cancer

Sponsor: City of Hope Medical Center

Conditions Metastatic Colon Carcinoma Metastatic Colorectal Carcinoma Metastatic Rectal Carcinoma RAS Family Gene Mutation Stage III Colon Cancer AJCC v7 Stage III Colorectal Cancer AJCC v7 Stage III Rectal Cancer AJCC v7 Stage IIIA Colon Cancer AJCC v7 Stage IIIA Colorectal Cancer AJCC v7 Stage IIIA Rectal Cancer AJCC v7 Stage IIIB Colon Cancer AJCC v7 Stage IIIB Colorectal Cancer AJCC v7 Stage IIIB Rectal Cancer AJCC v7 Stage IIIC Colon Cancer AJCC v7 Stage IIIC Colorectal Cancer AJCC v7 Stage IIIC Rectal Cancer AJCC v7 Stage IV Colon Cancer AJCC v7 Stage IV Colorectal Cancer AJCC v7 Stage IV Rectal Cancer AJCC v7 Stage IVA Colon Cancer AJCC v7 Stage IVA Colorectal Cancer AJCC v7 Stage IVA Rectal Cancer AJCC v7 Stage IVB Colon Cancer AJCC v7 Stage IVB Colorectal Cancer AJCC v7 Stage IVB Rectal Cancer AJCC v7
Interventions Laboratory Biomarker Analysis Trametinib Trifluridine and Tipiracil Hydrochloride
Updated 16 times since 2017 Last updated: Apr 4, 2024 Started: Apr 11, 2018 Primary completion: Jul 14, 2023 Completion: Jul 14, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Metastatic Colon Carcinoma and Metastatic Colorectal Carcinoma, this trial is completed. The trial is conducted by City of Hope Medical Center and has accumulated 16 data snapshots since 2018. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Nov 2017 – ~Apr 2018 · 5 months · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Aug 2019 · 8 months · monthly snapshot~Aug 2019 – ~Feb 2020 · 6 months · monthly snapshot~Feb 2020 – ~Sep 2020 · 7 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2022 · 13 months · monthly snapshot~Mar 2022 – ~Nov 2022 · 8 months · monthly snapshot~Nov 2022 – ~Apr 2023 · 5 months · monthly snapshot~Apr 2023 – ~May 2024 · 13 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

16 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. May 2024 — Jul 2024 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  4. Apr 2023 — May 2024 [monthly]

    Active Not Recruiting PHASE1

  5. Nov 2022 — Apr 2023 [monthly]

    Active Not Recruiting PHASE1

▶ Show 11 earlier versions

  1. Mar 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE1

  2. Feb 2021 — Mar 2022 [monthly]

    Active Not Recruiting PHASE1

  3. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE1

  4. Sep 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  5. Feb 2020 — Sep 2020 [monthly]

    Recruiting PHASE1

  6. Aug 2019 — Feb 2020 [monthly]

    Recruiting PHASE1

  7. Dec 2018 — Aug 2019 [monthly]

    Recruiting PHASE1

  8. Jun 2018 — Dec 2018 [monthly]

    Recruiting PHASE1

  9. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE1

  10. Apr 2018 — May 2018 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  11. Nov 2017 — Apr 2018 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • City of Hope Medical Center
  • National Cancer Institute (NCI)
Data source: City of Hope Medical Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations