Trial · 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
NCT03317119, Phase 1, Completed, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery. Trials, record NCT03317119. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03317119
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery
- NCT number
- NCT03317119
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead 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
- First posted
- 2017-10-23
- Last updated
- 2024-04-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose defined for the combination of trametinib, and Trifluridine and Tipiracil Hydrochloride (TAS?102) as the highest dose level at which 0-1 out of 6 patients experience dose limiting toxicities | Up to 28 days | Toxicities observed at each dose level will be categorized by type (organ affected or laboratory determination such as absolute neutrophil count), severity (by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] 4.0 and nadir or maximum values for the laboratory measures), time of onset (i.e., course number), duration, and reversibility or outcome. |
| Secondary | Incidence of adverse events assessed using NCI) CTCAE 4.0 | Up to 30 after last dose | Will be summarized in terms of type and severity, along with dose modification/delays that resulted. Analysis will be primarily descriptive. |
| Secondary | Objective response rate using Response Evaluation Criteria in Solid Tumor (RECIST) guideline, version 1.1 | Up to 1 year | |
| Secondary | Time to progression using RECIST guideline, version 1.1 | From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year | |
| Secondary | Overall survival | From start of treatment to death (any cause), assessed up to 1 year |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35738999 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03317119
GET https://conductscience.org/api/trials/v1/NCT03317119/registered