Clinical trial · Interventional
A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.
A Phase 1, Open-label, Non-randomized, Dose-escalating Safety, Tolerability, and Pharmacokinetic Study of TAS-102 in Combination With CPT-11 and Bevacizumab in Patients With Advanced Gastrointestinal Tumors
NCT01916447CI-TRIAL-00080454completedPhase 1ClinicalTrials.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 investigate the safety and determine the maximum tolerated dose of TAS-102 administered in combination with CPT-11 in patients with advanced gastrointestinal tumors.
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 Gastrointestinal Tumors | Digestive System Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| CPT-11 | Drug | — | UNRESOLVED |
| TAS-102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAS-102 and CPT-11 with or without Bevacizumab
- interventionNames
- Drug: TAS-102
- Drug: CPT-11
- Drug: Bevacizumab
Primary outcomes (2)
- measure
- Determine maximum tolerated dose
- timeFrame
- Through Cycle 1 and Cycle 2 (ie, 4 weeks)
- description
- The maximum tolerated dose is defined as the highest dose level at which less than 33% of the evaluable patients treated experience a dose-limiting toxicity during Cycle 1 or Cycle 2 (ie, during the first 4 weeks) of study drug administration.
- measure
- Safety monitoring including adverse events, vital signs, and laboratory assessments
- timeFrame
- Safety is assessed through 30 days following last administration of study medication or until initiation of new anticancer treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has provided written informed consent 2. Has advanced gastrointestinal tumors refractory to at least 1 chemotherapy 3. ECOG performance status of 0 or 1 4. Is able to take medications orally 5. Has adequate organ function (bone marrow, kidney and liver) 6. 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. Exclusion Criteria: 1. Has had certain other recent treatment e.g. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration 2. Presence of serious illnesses or medical condition(s) e.g. brain metastases, systemic infection, heart failure 3. Has unresolved toxicity of greater than or equal to CTCAE Grade 1 attributed to any prior therapies 4. Known sensitivity to TAS-102, CPT-11, Bevacizumab, or their components 5. Is a pregnant or lactating female 6. Has had either partial or total gastrectomy
References
Publications (0)
Data not yet available
No reference posted for this study.