A Single-Arm, Open-Label, Multi-Center, Phase Iv, Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma (Post Approval Commitment Study)
- 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.
- 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
- 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
- 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
- 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.