Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Dose escalation from Open label 0.05 to 0.25 mg/kg once a day dosing for 21 days |
|
| Group 2 | Experimental | Open label 0.10 mg/kg once a day dosing after safety evolution of Group 1 |
|
| Group 3 | Experimental | Open label 0.20 mg/kg once a day dosing after safety evolution of Group 2 |
|
| Group 4 | Experimental | Open label 0.25 mg/kg once a day dosing after safety evolution of Group 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-869 | Drug | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary tumor response | Every 6 week |
Not provided
Inclusion Criteria
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.
The subject exhibits evidence of other clinically significant uncontrolled condition(s).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susumu Matsuki, BS | Abbott Japan Co.,Ltd | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22382879 | Result | 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. |
Not provided
Not provided
| ID | Term |
|---|---|
| C513486 | linifanib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided