Phase 3
Completed N=406
Study of Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Cancer in Asia
Source: ClinicalTrials.gov NCT01955837 ↗Enrolled (actual)
406
Serious AEs
23.4%
Results posted
Nov 2020
Primary outcomePrimary: Overall Survival（OS） — 7.8; 7.1 Months — p=0.035
Summary
To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival（OS） |
7.8; 7.1 | 0.035 sig |
| SECONDARY Progression-free Survival (PFS) |
2.0; 1.8 | <0.001 sig |
| SECONDARY Time to Treatment Failure (TTF) |
1.9; 1.8 | <0.001 sig |
| SECONDARY Overall Response Rate (ORR; Complete Response [CR] or Partial Response [PR] Using RECIST Criteria) |
1.1; 0.0 | 0.554 |
| SECONDARY Disease Control Rate (DCR; CR, PR, or Stable Disease) |
44.1; 14.6 | <0.001 sig |
| SECONDARY Duration of Response |
6.6; 0 | <0.001 sig |
| SECONDARY Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments（Adverse Events） |
2; 15; 269; 120; 269; 118 | — |
| SECONDARY Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments（Laboratory Assessments） |
209; 52; 48; 8; 190; 4 | — |
| SECONDARY Overall Survival（OS）(Wild Type KRAS) |
8.6; 7.4 | 0.083 |
| SECONDARY Overall Survival（OS）(Mutant Type KRAS) |
7.0; 6.5 | 0.228 |
| SECONDARY Progression-free Survival (PFS) (Wild Type KRAS) |
2.0; 1.8 | — |
| SECONDARY Progression-free Survival (PFS) (Mutant Type KRAS) |
2.2; 1.8 | — |
Eligibility Criteria
Inclusion Criteria
- Has provided written informed consent
- Has adenocarcinoma of the colon or rectum
- Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Is able to take medication orally
- Has adequate organ function (bone marrow, kidney and liver)
- Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Data sourced from ClinicalTrials.gov (NCT01955837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.