A Phase 1 Study of ABT-869 in Subjects With Solid Tumors

An Open Label, Phase I Study Evaluating Pharmacokinetics, Safety, and Tolerability of ABT-869 in Subjects With Solid Tumors

The objective of this study is to evaluate the pharmacokinetics, safety and tolerability of ABT-869 in Japanese patients with solid tumors up to the Recommended Phase Two Dose that was determined in a previous the M04-710 study.

Inclusion Criteria

• Subjects aged from 20 to 75 years and ECOG PS of 0-2 at screening.
• Subject must have a solid tumor that is refractory to standard therapies or for which a standard effective therapy does not exist.
• The subject must have adequate bone marrow, renal and hepatic function.
• Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and up to six months following completion of therapy.
• The subject must voluntarily sign and date an informed consent.

Exclusion Criteria

• The subject currently exhibits symptomatic or intervention indicated CNS metastasis.

• The subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational therapy within 4 weeks of enrollment or has not fully recovered from toxicity resulting from past treatment(s) that affects the assessments in this study at the enrollment.

• The subject with the following conditions during screening assessment.

  1. proteinuria CTC grade > 1 as measured by urinalysis and 24 hour urine collection
  2. diastolic blood pressure (BP) > 95 mmHg; or systolic blood pressure (BP) > 150 mmHg
  3. a history of or currently exhibits clinically significant cancer related events of bleeding
  4. LV Ejection Fraction < 50%
  5. received a cumulative dose of Anthracycline > 360 mg/m2 for treatment of cancer
  6. receiving therapeutic anticoagulation therapy
  7. having fractures except for chronic bone lesion due to bone metastases

• The subject exhibits evidence of other clinically significant uncontrolled condition(s).