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

Study Overview
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Brief Summary
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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.

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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: ABT-869


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Dose escalation from Open label 0.05 to 0.25 mg/kg once a day dosing for 21 days | Drug: ABT-869<br>* 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.<br>|
| Experimental: Group 2<br>Open label 0.10 mg/kg once a day dosing after safety evolution of Group 1 | Drug: ABT-869<br>* 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.<br>|
| Experimental: Group 3<br>Open label 0.20 mg/kg once a day dosing after safety evolution of Group 2 | Drug: ABT-869<br>* 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.<br>|
| Experimental: Group 4<br>Open label 0.25 mg/kg once a day dosing after safety evolution of Group 3 | Drug: ABT-869<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary tumor response |  | Every 6 week |