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Advanced Solid TumorsPhase 1NCT00733187

Pharmacokinetic Study To Evaluate Effect of Food and Diurnal Variation on ABT-869

A Phase 1 study testing ABT-869 in people with Advanced Solid Tumors, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To estimate the effect of food on the oral bioavailability and effect of diurnal variation on the pharmacokinetics of ABT-869. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
ABT-869
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
No sites listed yet
Study dates
Feb 2009to Jun 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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.
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  • 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 (HIV).
  • 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.

About this study

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

To estimate the effect of food on the oral bioavailability and effect of diurnal variation on the pharmacokinetics of ABT-869.

Read the detailed description

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.

Being tested
ABT-869

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-869Drug

    0.25 mg/kg

Study groups in NCT00733187
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: ABT-869

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic

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

    Measured: Various timepoints

  2. ECG Evaluation

    Triplicate ECG will be performed at designated timepoints.

    Measured: Various timepoints

  3. Adverse Events

    Only treatment emergent AEs will be included. Toxicity grade, relationship to study drug and AEs leading to discontinuation will be evaluated.

    Measured: Throught the study

  4. 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.

    Measured: Various timepoints

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2008 (estimated)
  2. Study startFeb 2009
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00733187
Sponsor's protocol ID
M10-384
Status last verified
Jan 2013
First submitted
8 Aug 2008
Last updated
21 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24810181

  • 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.

    PubMed 24241212

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-869 in people with Advanced Solid Tumors, run by AbbVie (prior sponsor, Abbott).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic (time frame: Various timepoints). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00733187, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.

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