Status:
COMPLETED
A Phase 1 Study of ABT-869 in Subjects With Solid Tumors
Lead Sponsor:
AbbVie
Conditions:
Solid Tumor
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
- proteinuria CTC grade \> 1 as measured by urinalysis and 24 hour urine collection
- diastolic blood pressure (BP) \> 95 mmHg; or systolic blood pressure (BP) \> 150 mmHg
- a history of or currently exhibits clinically significant cancer related events of bleeding
- LV Ejection Fraction \< 50%
- received a cumulative dose of Anthracycline \> 360 mg/m2 for treatment of cancer
- receiving therapeutic anticoagulation therapy
- having fractures except for chronic bone lesion due to bone metastases
- The subject exhibits evidence of other clinically significant uncontrolled condition(s).
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00718380
Start Date
September 1 2008
End Date
June 1 2012
Last Update
November 21 2017
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