Clinical trial · Interventional
Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer
An Open-Label, Multi-center, Phase 2 Study of Switch Maintenance With TAS-102 Plus Bevacizumab Following Oxaliplatin or Irinotecan-Based Fluoropyrimidine-Containing Induction Chemotherapy in Patients With Metastatic Colorectal Cancer
NCT02654639CI-TRIAL-00034189ALEXANDRIAterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal investigator left the institution
Summary
Brief summary (as posted)
Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| TAS-102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAS-102 and Bevacizumab
- description
- Oral TAS-102 and intravenous Bevacizumab.
- interventionNames
- Drug: TAS-102
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Length of Progression-Free Survival
- timeFrame
- From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.
- description
- Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Written informed consent * Histologically proven, unresectable, evaluable metastatic colorectal cancer * 16 to 20 weeks of first-line therapy with oxaliplatin, and/or irinotecan-based flourorpyrimidine-containing chemotherapy plus Bevacizumab * Patients must have stable disease (or better) during the initial induction chemotherapy with first-line chemotherapy. * No progressive disease at the time of initiation of maintenance therapy * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 * Adequate organ and marrow function * Women of child-bearing potential and men must agree to avoid pregnancy * Patient must start maintenance therapy at least 14 days after the last administered induction chemotherapy but no later than 30 days. Exclusion Criteria * Patients whose tumors have progressed on first-line treatment * Patients with active concurrent malignancy, other than superficial, non-invasive squamous cell carcinoma of the skin or uterine cervix, within the past three years. * Women who are pregnant or lactating * Unstable heart disease * Uncontrolled active infection requiring antibiotics within one week prior to first dose. * Patients with active CNS malignancy. * Persistent protein in the urine * Patients with bowel obstruction or uncontrolled vomiting. * Patients with serious psychiatric or medical conditions that could interfere with treatment.
References
Publications (1)
- DERIVEDWeinberg BA, Hartley ML, Salem ME. Precision Medicine in Metastatic Colorectal Cancer: Relevant Carcinogenic Pathways and Targets-PART 2: Approaches Beyond First-Line Therapy, and Novel Biologic Agents Under Investigation. Oncology (Williston Park). 2017 Jul 15;31(7):573-80. PMID 28712102