Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03274882 | Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies | PHASE2 | COMPLETED | 26 | — | — | Mar 3, 2017 | Dec 3, 2018 | Jul 25, 2024 | 2 | Russia |
percentage of patients alive without investigator-assessed radiological disease progression according to RECIST 1.1 after 2 months
| Arm | Type | Description |
|---|---|---|
| S95005 | EXPERIMENTAL | Film-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride (with a molar ratio of 1:0.5) was administered at 35 mg/m²/dose orally twice a day, within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period. This treatment cycle was repeated every 4 weeks until treatment withdrawal criteria are met. |
| Name | Type | Description |
|---|---|---|
| S95005 | DRUG | The treatment is given in open manner. It was administered until unacceptable toxicity according to the investigator, disease progression or patient withdrawal. If a patient discontinues study treatment for reasons other than radiologic disease progression (e.g., intolerable side effects), the patient was followed for tumour response until radiologic disease progression or initiation of new anticancer therapy (whichever occurs first). |
Inclusion Criteria: * Male or female aged ≥18 years of age * Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum * Has received at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (including fluoropyrimidines, irinotecan a...