Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery
Public ClinicalTrials.gov record NCT03317119. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03317119
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 26 participants
Conditions and interventions
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
Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 11, 2018 (Actual)
- Primary completion
- Jul 14, 2023 (Actual)
- Completion
- Jul 14, 2023 (Actual)
- Last update posted
- Apr 8, 2024
2018 – 2023
United States locations
- U.S. sites
- 8
- U.S. states
- 1
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Corona | Corona | California | 92879 | — |
| City of Hope Medical Center | Duarte | California | 91010 | — |
| City of Hope Antelope Valley | Lancaster | California | 93534 | — |
| City of Hope Mission Hills | Mission Hills | California | 91345 | — |
| City of Hope Rancho Cucamonga | Rancho Cucamonga | California | 91730 | — |
| City of Hope - Santa Clarita | Santa Clarita | California | 91355 | — |
| City of Hope South Pasadena | South Pasadena | California | 91030 | — |
| City of Hope West Covina | West Covina | California | 91790 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03317119, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 8, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03317119 live on ClinicalTrials.gov.