Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAS-102 · 1 trial · 2 indications
Percent of patients positive for ctDNA after 6 cycles or at least 3 months months after starting adjuvant treatment will be used to estimate the efficacy of adjuvant trifluridine and tipiracil (TAS102) in combination with irinotecan in patients with ctDNA positive colon adenocarcinoma. The Signatera MRD ctDNA Assay will be used to measure ctDNA positivity.
| Arm | Type | Description |
|---|---|---|
| TASIRI | EXPERIMENTAL | Patients randomized to the experimental arm ("TASIRI") will be treated with TAS-102 25mg/m2 p.o. on days 1-5 and irinotecan 180mg/m2 i.v. on day 1 every 14 days. If ANC \<1500/uL on day 1 of a cycle, then G-CSF will be added on day 6 for three days. |
| Name | Type | Description |
|---|---|---|
| TAS-102 | DRUG | Given PO |
| Irinotecan | DRUG | Given IV |
| Standard Treatment | COMBINATION_PRODUCT | 6 cycles for a 2-week regimen (infusional 5FU based) and up to 4 cycles for a 3-week regimen (oral capecitabine based) after randomization |
| Signatera MRD ctDNA Assay | DIAGNOSTIC_TEST | To be performed within 6-8 weeks of Cycle 1 Day 1. A Mid-treatment ctDNA is to be completed within 6 - 8 weeks of starting treatment. ctDNA is to also be completed within four weeks after completion of study treatment (+/- two weeks) |
Inclusion Criteria: 1. Patients must have histologically or cytologically confirmed adenocarcinoma of the colon (high rectal cancer is eligible if resected and no radiation needed). Other histologies which are treated per NCCN guidelines for adjuvant colon cancer are eligible. 2. Must have Stage II...
TAS-102 is an investigational small molecule being studied for use in colon adenocarcinoma. It is currently in Phase 1 clinical development for this indication. The drug is being evaluated in patients with refractory minimal residual disease in colon adenocarcinomas, as part of an ongoing clinical trial.
TAS-102 is being developed by Natera, Inc., a company traded on the NASDAQ under the ticker symbol NTRA. The company is conducting a Phase 1 clinical trial of TAS-102 in patients with colon adenocarcinoma and colorectal cancer in the United States.
TAS-102 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients with colon adenocarcinoma and colorectal cancer, with a target enrollment of 22 participants.
TAS-102 is being studied in a Phase 1 clinical trial registered as NCT04920032. The trial is titled 'Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas' and is currently recruiting patients in the United States. The study enrolls adults aged 18 years and older.
TAS-102 is the drug name used in the clinical trial NCT04920032. No alternative names for this drug have been disclosed in the trial information. The drug is being investigated as a monotherapy in an uncontrolled, non-randomized, open-label study design for colon adenocarcinoma.