Trials / Completed
CompletedNCT03317119
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) for the combination of trametinib and trifluridine and tipiracil hydrochloride (TAS-102) in patients with chemotherapy-resistant metastatic colorectal cancer. SECONDARY OBJECTIVES: I. Describe the safety of the combination of trametinib and TAS-102 across all investigated dose levels. II. Describe the clinical activity including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of the combination in an expansion cohort using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. OUTLINE: Patients receive trifluridine and tipiracil hydrochloride orally (PO) twice daily (BID) on days 1-5 and 8-12 and trametinib PO once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then bi-annually thereafter.
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
| Type | Name | Description |
|---|---|---|
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| DRUG | Trametinib | Given PO |
| DRUG | Trifluridine and Tipiracil Hydrochloride | Given PO |
Timeline
- Start date
- 2018-04-11
- Primary completion
- 2023-07-14
- Completion
- 2023-07-14
- First posted
- 2017-10-23
- Last updated
- 2024-04-08
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03317119. Inclusion in this directory is not an endorsement.