An Open Label, Phase I Study Evaluating Pharmacokinetics, Safety, and Tolerability of ABT-869 in Subjects With Solid Tumors
- 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.
- 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
3. a history of or currently exhibits clinically significant cancer related events
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