Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Sunitinib Malate (SU011248)
Intervention description: Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.
Intervention MeSH terms: Sunitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sunitinib Phase IV metastatic renal cell carcinoma Chinese

Summary:

      To investigate safety and efficacy of single agent sunitinib malate as first-line systemic
      therapy in Chinese patients with metastatic renal cell carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed renal cell carcinoma with metastases with a component of
             clear (conventional) cell histology that is not amenable to surgery.

          -  Evidence of unidimensionally measurable disease

          -  Male or female, 18 years of age or older.

          -  ECOG performance status 0 or 1.

          -  Resolution of all acute toxic effects

          -  Adequate organ function.

        Exclusion Criteria:

          -  Renal cell carcinoma without any clear (conventional) cell component.

          -  Prior systemic therapy for metastatic disease of any kind of RCC, such as Interferon
             or Interleukin, chemotherapy, hormonal, investigational or targeted therapies.
             Patients may have received prior adjuvant therapy with Interferon and/or Interleukin
             if recurrence occurred > 6 months after adjuvant therapy completion.

          -  Major surgery or radiation therapy <4 weeks of starting the study treatment. Prior
             palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at
             least one measurable lesion that has not been irradiated.

          -  NCI CTCAE grade 3 hemorrhage <4 weeks of starting the study treatment.

          -  Diagnosis of any second malignancy within the last 5 years, except for adequately
             treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer.

          -  History of or known brain metastases, spinal cord compression, or carcinomatous
             meningitis, or evidence of brain or leptomeningeal disease on screening CT or MRI
             scan.

          -  Any of the following within the 12 months prior to study drug administration:
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, symptomatic congestive heart failure, cerebrovascular accident or transient
             ischemic attack, and 6 months for pulmonary embolism.

          -  Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
             the normal range with medication.

          -  Ongoing cardiac dysrhythmias, atrial fibrillation, or prolongation of the QTc interval
             to >450 msec for males or >470 msec for females.

          -  Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal
             medical therapy).

          -  Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO
             daily for deep vein thrombosis prophylaxis is allowed).

          -  Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
             (AIDS)-related illness.

          -  Current treatment on another clinical trial.

          -  Pregnancy or breastfeeding. Female patients must be surgically sterile or be
             postmenopausal, or must agree to use effective contraception during the period of
             therapy. All female patients with reproductive potential must have a negative
             pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically
             sterile or must agree to use effective contraception during the period of therapy. The
             definition of effective contraception will be based on the judgment of the principal
             investigator or a designated associate.

          -  Other severe acute or chronic medical or psychiatric condition, or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration, or may interfere with the interpretation of study results, and in
             the judgment of the investigator would make the patient inappropriate for entry into
             this study.