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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
Phase 1 trial testing Laboratory Biomarker Analysis in Metastatic Colon Carcinoma in 26 participants. Completed in 14 July 2023.
14 July 2023
Quick facts
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 11 April 2018 |
| Primary completion | 14 July 2023 |
| Estimated completion | 14 July 2023 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- Laboratory Biomarker Analysis — full drug profile →
- Trametinib (trametinib) — full drug profile →
- Trifluridine and Tipiracil Hydrochloride (trifluridine-and-tipiracil-hydrochloride) — full drug profile →
Conditions studied
- Metastatic Colon Carcinoma — all drugs for Metastatic Colon Carcinoma →
- Metastatic Colorectal Carcinoma — all drugs for Metastatic Colorectal Carcinoma →
- Metastatic Rectal Carcinoma — all drugs for Metastatic Rectal Carcinoma →
- RAS Family Gene Mutation — all drugs for RAS Family Gene Mutation →
Sponsor
City of Hope Medical Center
Who can join
18 and older, any sex, with Metastatic Colon Carcinoma or Metastatic Colorectal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial studies the side effects and best dose of trametinib and trifluridine and tipiracil hydrochloride in treating patients with colon or rectal cancer that has spread to other places in the body (advanced/metastatic) or cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as trifluridine and tipiracil hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib and trifluridine and tipiracil hydrochloride may prevent cancer cells from dividing and work better in treating patients with colon and rectal cancer.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Strategies to tackle RAS-mutated metastatic colorectal cancer.
Patelli G, Tosi F, Amatu A, Mauri G, et al · · 2021 · cited 65× · PMID 34044286 · DOI 10.1016/j.esmoop.2021.100156 -
The Relevance of Transcription Factors in Gastric and Colorectal Cancer Stem Cells Identification and Eradication.
Pádua D, Figueira P, Ribeiro I, Almeida R, et al · · 2020 · cited 34× · PMID 32626705 · DOI 10.3389/fcell.2020.00442 -
c-MYC Protein Stability Is Sustained by MAPKs in Colorectal Cancer.
Lepore Signorile M, Grossi V, Fasano C, Forte G, et al · · 2022 · cited 12× · PMID 36230763 · DOI 10.3390/cancers14194840 -
Integrating Academic and Community Practices in the Management of Colorectal Cancer: The City of Hope Model.
Karimi M, Wang C, Bahadini B, Hajjar G, et al · · 2020 · cited 7× · PMID 32498251 · DOI 10.3390/jcm9061687 -
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.
Chuang J, Gong J, Li SM, Wang C, et al · · 2022 · cited 4× · PMID 35738999 · DOI 10.1016/j.clcc.2022.05.004 -
Efficacy and Safety of Trifluridine/Tipiracil-Containing Combinations in Colorectal Cancer and Other Advanced Solid Tumors: A Systematic Review.
Shitara K, Falcone A, Fakih MG, George B, et al · · 2024 · cited 3× · PMID 38366864 · DOI 10.1093/oncolo/oyae007
Verify or expand the search:
- PubMed search for NCT03317119
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Metastatic Colon Carcinoma
Currently open trials in the same condition.
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Other City of Hope Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03317119 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
- Last refreshed: 8 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03317119.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing