Study of Fruquintinib in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: fruquintinib; placebo
Intervention description: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off; Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Colorectal cancer; Fruquintinib; 013

Summary:

      Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and
      one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor
      activity in patients with advanced Colorectal Cancer (CRC) in Phase Ib study.

      This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of
      patients with metastatic CRC who have progressed after metastatic CRC second line or above
      standard chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 and ≤ 75 years of age , with ≥ 40 Kg

          -  Histological or cytological confirmed metastatic colorectal cancer

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Failed 2 or more lines of chemotherapy

          -  Adequate hepatic, renal, heart, and hematologic functions

          -  At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)

          -  Signed and dated informed consent.

          -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory
             tests, and other study procedure

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Any factors that influence the usage of oral administration

          -  Central nervous system (CNS) metastasis

          -  One of the following conditions: non-controlled hypertension, coronary artery disease,
             arrhythmia and heart failure

          -  Abuse of alcohol or drugs

          -  Less than 4 weeks from the last clinical trial - Previous treatment with VEGFR
             inhibition

          -  Disability of serious uncontrolled intercurrence infection

          -  Proteinuria ≥ 2+ (1.0g/24hr)

          -  Evidence or a history of bleeding tendency within two months of the enrollment,
             regardless of seriousness

          -  History of artery/venous thromboembolic events in 12 months, such as cerebral vascular
             accident (including transient ischemic attack) etc.

          -  History of acute myocardial infarction, acute coronary syndrome or coronary artery
             bypass graft (CABG) in 6 months

          -  Bone fracture or wounds that was not cured for a long time

          -  Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy