Clinical trial · Interventional
Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer
A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer
NCT00824161CI-TRIAL-00006764terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate progression free survival primarily. The secondary objectives are to evaluate the antitumor activity, as assessed by objective tumor response, duration of clinical benefit, overall survival, and the safety profile of TAS-109
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAS-109 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- TAS-109
- interventionNames
- Drug: TAS-109
Primary outcomes (1)
- measure
- Percentage of Progression Free Survival
- timeFrame
- From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months.
- description
- The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy.
Secondary outcomes (2)
- measure
- Antitumor Activity
- timeFrame
- From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed colorectal adenocarcinoma * Received prior therapy, at least two regimens, containing a fluoropyrimidine, oxaliplatin, and irinotecan * Have at least one measurable tumor, as defined by RECIST * Must be capable of maintaining a central venous line access Exclusion Criteria: * Had previous anti-tumor therapy in the 3 weeks prior to study entry * Have not recovered from all toxicities (excluding alopecia) from prior therapy to baseline or ≤grade 1 prior to study entry * Have another malignancy in the past 3 years except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
References
Publications (0)
Data not yet available
No reference posted for this study.