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

Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC

Study Drug:

TAS-102 (trifluridine and tipiracil hydrocholoride) and bevacizumab

Dosing Details:

Starting dose of TAS-102 is 35 mg/m2 administered orally twice daily, after meals, for 5 days a week with 2 days rest for 14 days, followed by 14 days rest (1 treatment cycle).

Bevacizumab 5 mg/kg intravenously every 14 days. The treatment cycle repeats every 28 days. Patients may take TAS-102 plus bevacizumab until they exhibit progression of disease, withdraw consent, or experience unacceptable toxicity.This is a single arm study. All patients receive the same study treatment.

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.