ABOUT THIS STUDY
- Histologically confirmed locally recurrent or metastatic renal cell carcinoma of clear cell origin or with a component of clear cell histology.
- Patients with nephrectomy (partial or total) or without nephrectomy are eligible.
- Evidence of measurable disease by RECIST criteria version 1.1.
- Male or female, age ≥ 18 years old
- Karnofsky performance status ≥ 80 %.
- Adequate organ functions determined by protocol directed lab values
- Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Renal cell carcinoma without any clear (conventional) cell component.
- Prior systemic therapy of any kind for advanced RCC (including targeted therapy,
immunotherapy, chemotherapy, hormonal, or investigational therapy). Prior neo-adjuvant
or adjuvant therapy with cytokines, IL-2 or vaccines is only permitted if it did not
occur within the preceding 12 months. Prior and/or concurrent bisphosphonate therapy
- Major surgery or radiation therapy within 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 Version 3.0 grade 3 haemorrhage within 4 weeks of starting the study
- 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
- Known brain metastases, spinal cord compression, or evidence of symptomatic brain or
leptomeningeal carcinomatosis on screening CT or MRI scan.
- Any of the following within the 6 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, or pulmonary embolism
- Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade ≥2
- Prolonged QTc interval on baseline EKG (>450 msec for males or >470 msec for females).
- Atrial Fibrillation of any grade.
- Uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness or other active infection.
- Concurrent treatment on another clinical trial. Supportive care trials or
non-treatment trials, e.g. QOL, and imaging trials are allowed.
- Concomitant treatment with a drug having proarrhythmic potential
- Use of potent CYP3A4 inhibitors and inducers 7 and 12 days before dosing, respectively
- Pregnancy or breastfeeding. Female subjects must be surgically sterile or be
postmenopausal, or must agree to use effective contraception during the period of
therapy. All female subjects with reproductive potential must have a negative
pregnancy test (serum) prior to enrolment. Male subjects 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 subject inappropriate for entry into
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