Phase 1 Multiple Ascending Dose Study of XL184 Monotherapy in Japanese Subjects With Advanced or Metastatic Solid Tumors
- Subjects with advanced or metastatic solid tumors for whom the standard of care is
ineffective or inappropriate.
- At least 4 weeks must have elapsed from the last anti-cancer therapy. At least 6
weeks for nitrosoureas, mitomycin C and liposomal doxorubicin.
- Have adequate bone marrow function, adequate liver function, and adequate renal
- Men and women, 20 years of age and above. Sexually active subjects (men and women)
must agree to use medically accepted barrier methods of contraception (eg, male or
female condom) during the course of the study and for 3 months after the last dose of
study drug(s), even if oral contraceptives are also used. All subjects of
reproductive potential must agree to use both a barrier method and a second method of
birth control. Women of childbearing potential (WOCBP) must have a negative pregnancy
test at screening.
- Symptomatic central nervous system (CNS) metastasis, or active CNS metastasis
- WOCBP who are unwilling or unable to use an acceptable method of contraception to
avoid pregnancy for the entire study period and for 12 weeks after the last dose of
- Women who are pregnant or breastfeeding
- Sexually active fertile men not using effective birth control for the entire study
period and for 12 weeks after the last dose of investigational product if their
partners are WOCBP.
- The subject has uncontrolled intercurrent illness including, but not limited to,
infection requiring systemic therapy, symptomatic congestive heart failure,
uncontrolled hypertension, uncontrolled angina pectoris, uncontrolled peptic ulcer,
cardiac arrhythmia requiring medication.
- Subject who is HIV antibody positive, HBs antigen positive, and/or HCV antibody
positive within 6 months.
- Subjects with body cavity fluid retention which requires drainage.
- Subjects with any major surgery within 4 weeks prior to study enrollment.
- Subjects with major unhealed wounds or fracture (those with chronic pathological
fracture are allowed to be enrolled).
- Subjects with a history or concurrent diagnosis of gastrointestinal perforation.
- Subjects with evidence of bleeding tendency or coagulopathy.
- Subjects with a history of thromboembolism.
- Subjects with a history of or concurrent pancreatitis.
- Exposure to any investigational drug within 30 days of enrollment.