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A Pharmacokinetic Study to Evaluate the Effect of Food on the Oral Bioavailability and Effect of Diurnal Variation on the Pharmacokinetics of ABT-869

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

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Trial Information

A Pharmacokinetic Study to Evaluate 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.

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:

- Bone Marrow: Absolute neutrophil count (ANC) ≥ 1,500/mm³; Platelets ≥
100,000/mm³; Hemoglobin ≥ 9.0 g/dL (1.4 mmol/L)

- Renal function: serum creatinine ≤ 2.0 mg/dL (0.81 mmol/L);

- Hepatic function: AST and ALT ≤ 1.5 × ULN unless liver metastases are present,
then AST and ALT ≤ 5.0 × ULN; bilirubin ≤ 1.5 mg/dL (0.026 mmol/L)

- 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.

- total abstinence from sexual intercourse (minimum one complete menstrual cycle);

- a vasectomized partner;

- hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months
prior to study drug administration;

- intrauterine device; * double-barrier method (condoms, contraceptive sponge,
diaphragm or vaginal ring with spermicidal jellies or cream)

- 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:

- Has received anti-cancer therapy within 21 days or within a period defined by 5 half
lives, whichever is shorter, prior to study drug administration. Has not recovered to
less than or equal to Grade 1 clinically significant adverse effects/toxicities of
the previous therapy. Avastin must not have been used less than 60 days prior to
receiving ABT-869.

- Has had major surgery within 21 days of Study Day 1.

- Has untreated brain or meningeal metastases. Subjects with treated, stable,
asymptomatic central nervous system lesions may be considered. Subject must have had
stable disease for at least 4 weeks prior to study entry.

- Has been diagnosed with hepatocellular carcinoma.

- Pregnant or breastfeeding female.

- Is receiving therapeutic anticoagulation therapy. Low dose anticoagulation for
catheter prophylaxis will be permitted.

- Has a history of/or currently exhibits clinically significant cancer related events
of bleeding. The subject has a recent history of (within 4 weeks of Study Day 1) or
currently exhibits other clinically significant signs of bleeding.

- Has proteinuria CTC Grade > 1 at baseline as measured by a UPC ratio of > 1 and
confirmed by a 24 hour urine collection. . Currently exhibits symptomatic or
persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 100
mmHg; or systolic blood pressure (BP) > 150 mmHg.

- Has a history of myocardial infarction within 6 months of Study Day 1.

- Has known autoimmune disease with renal involvement.

- Is receiving combination anti-retroviral therapy for human immunodeficiency virus

- Clinically significant uncontrolled condition(s).

- Has active ulcerative colitis, Crohn's disease or celiac disease.

- LV Ejection Fraction < 50%.

- Current or previous enrollment in another clinical study.

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:


Outcome Description:

Blood samples for the pharmacokinetics of linifanib will be collected for each subject and each regimen (fasting, fed, AM and PM dosings).

Outcome Time Frame:

Various timepoints

Safety Issue:


Principal Investigator

Justin Ricker, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2009

Completion Date:

June 2012

Related Keywords:

  • Advanced Solid Tumors



Site Reference ID/Investigator# 10223Detroit, Michigan  48201