Solid Tumor
Conditions
Brief summary
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.
Interventions
DRUGABT-869
2.5 mg or 10 mg tablet, Once a day, oral dose, dose per body weight (dose determined by group; 2.5mg or 10mg tablet) until evidence of uncontrolled unacceptable toxicity or disease progression. For more information, please see Arm Description.
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety tolerability assessment | Weekly assessment for 3 weeks then every 3 weeks or more frequently as needed |
| Dose limiting toxicity determination | Weekly assessment for the first 3 weeks |
| Pharmacokinetic profile evaluation | Day 1 and Day 15 |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary tumor response | Every 6 week |
Outcome results
None listed