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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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To estimate the effect of food on the oral bioavailability and effect of diurnal variation on the pharmacokinetics of ABT-869.
This study is a pharmacokinetic study designed to evaluate the effect of food on the oral bioavailability and effect of diurnal variation on the pharmacokinetics of ABT-869. Triplicate ECG performed to determine the effect of ABT-869 on QT prolongation . Subjects may continue receiving linifanib after completion of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-869 | Drug | 0.25 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic | Blood samples for the pharmacokinetics of linifanib will be collected for each subject and each regimen (fasting, fed, AM and PM dosings). | Various timepoints |
| ECG Evaluation | Triplicate ECG will be performed at designated timepoints. | Various timepoints |
| Adverse Events | Only treatment emergent AEs will be included. Toxicity grade, relationship to study drug and AEs leading to discontinuation will be evaluated. | Throught the study |
| Lab data and vital signs | Blood chemistry and hematology will be analyzed based on the regimen and dosing and overall. 24 hr ABPM will be analyzed by regimen and dosing time and overall. | Various timepoints |
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Inclusion Criteria:
Male or female and age is ≥ 18 years.
Must have a histologically or cytologically confirmed non-hematologic malignancy that is refractory to standard therapies or for which a standard effective therapy does not exist.
Has measurable or evaluable disease.
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
Must have adequate bone marrow, renal and hepatic function as follows:
Must have PTT ≤ 1.5 × ULN and/or INR ≤ 1.5 .
Women of childbearing potential and men must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and up to two months following completion of therapy. Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment and/or post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
Is capable of understanding and complying with parameters as outlined in the protocol and able to sign the informed consent.
Must voluntarily sign and date each informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Ricker, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24810181 | Result | Xiong H, Chiu YL, Ricker JL, LoRusso P. Results of a phase 1, randomized study evaluating the effects of food and diurnal variation on the pharmacokinetics of linifanib. Cancer Chemother Pharmacol. 2014 Jul;74(1):55-61. doi: 10.1007/s00280-014-2475-z. Epub 2014 May 9. | |
| 24241212 | Derived | Chiu YL, Lorusso P, Hosmane B, Ricker JL, Awni W, Carlson DM. Results of a phase I, open-label, randomized, crossover study evaluating the effects of linifanib on QTc intervals in patients with solid tumors. Cancer Chemother Pharmacol. 2014 Jan;73(1):213-7. doi: 10.1007/s00280-013-2351-2. Epub 2013 Nov 16. |
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| ID | Term |
|---|---|
| C513486 | linifanib |
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