A Phase 1 Study of ABT-869 in Subjects With Solid Tumors
NCT ID: NCT00718380
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2008-09-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group 1
Dose escalation from Open label 0.05 to 0.25 mg/kg once a day dosing for 21 days
ABT-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.
Group 2
Open label 0.10 mg/kg once a day dosing after safety evolution of Group 1
ABT-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.
Group 3
Open label 0.20 mg/kg once a day dosing after safety evolution of Group 2
ABT-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.
Group 4
Open label 0.25 mg/kg once a day dosing after safety evolution of Group 3
ABT-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.
Interventions
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ABT-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.
Eligibility Criteria
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Inclusion Criteria
* 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 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).
20 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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Susumu Matsuki, BS
Role: STUDY_DIRECTOR
Abbott Japan Co.,Ltd
Countries
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References
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Asahina H, Tamura Y, Nokihara H, Yamamoto N, Seki Y, Shibata T, Goto Y, Tanioka M, Yamada Y, Coates A, Chiu YL, Li X, Pradhan R, Ansell PJ, McKeegan EM, McKee MD, Carlson DM, Tamura T. An open-label, phase 1 study evaluating safety, tolerability, and pharmacokinetics of linifanib (ABT-869) in Japanese patients with solid tumors. Cancer Chemother Pharmacol. 2012 Jun;69(6):1477-86. doi: 10.1007/s00280-012-1846-6. Epub 2012 Mar 2.
Other Identifiers
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M10-227
Identifier Type: -
Identifier Source: org_study_id