- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01506934
A Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
August 24, 2012 updated by: Abbott
A Phase 1, Open Label, Randomized, Adaptive, Cross-Over Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
A pharmacokinetic study to compare 2 clinical formulations of linifanib and the effect of food on the pharmacokinetics of linifanib.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This study is designed to evaluate the bioavailability of linifanib from two formulations and the effect of food on the pharmacokinetics of the linifanib formulation intended for commercialization.
Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21231
- Site Reference ID/Investigator# 51465
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Michigan
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Detroit, Michigan, United States, 48201
- Site Reference ID/Investigator# 61282
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0001
- Site Reference ID/Investigator# 51463
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Texas
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San Antonio, Texas, United States, 78229
- Site Reference ID/Investigator# 52122
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Age is greater than or equal to 18 years.
- Subject must have a histologically or cytologically confirmed non-hematologic malignancy other than Hepatocellular Carcinoma (HCC).
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
Subject must have adequate bone marrow, renal and hepatic function as follows:
- Bone Marrow: Absolute neutrophil count (ANC) >= 1,500/mm3 (1.5 X 109/L); Platelets >= 75,000/mm3 (75 X 109/L); 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 X ULN unless liver metastases are present, then AST and ALT <= 5.0 X ULN; bilirubin <= 1.5 mg/dL (0.026 mmol/L)
- Subject must have Partial Thromboplastin Time (PTT) </= 1.5 x Upper Limit of Normal ( ULN) and International Normalized Ratio (INR) </= 1.5.
Exclusion Criteria
- Subject has received anti-cancer therapy including investigational agents, cytotoxic chemotherapy, radiation therapy or biologic therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration. In addition subject has not recovered to less than or equal to Grade 1 clinically significant adverse effects/toxicities of the previous therapy.
- Subject has undergone major surgery within 21 days of Period 1, Study Day 1.
- Subject has untreated brain or meningeal metastases. Subjects with treated brain metastases that are radiographically or clinically stable (for at least 4 weeks after therapy) and who have no evidence of cavitation or hemorrhage in the brain lesion, are eligible provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to Study Day 1, Period 1).
- Current enrollment in another clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: linifanib
Single Doses
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Single Dose on Day 1 of Periods 1, 2 and 3 (Bioavailability Portion) Single Dose on Day 1 of Periods 1 and 2 (Food Effect Portion)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Calculate the Cmax and Tmax of participating subjects
Time Frame: PK parameters will be measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose in each study period.
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PK parameters will be measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose in each study period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
Time Frame: All adverse events occuring from Day 1 of Period 1 through the Final Visit will be reported.
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The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis on Days 1 through 7 of Periods 1, 2 and 3.
The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the case report forms.
All adverse events will be followed to a satisfactory clinical resolution.
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All adverse events occuring from Day 1 of Period 1 through the Final Visit will be reported.
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Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.
Time Frame: Physical exam at Screening, Day 1 of Periods 1, 2 and 3 and Day 5, Period 2 (FE portion), Day 5, Period 3 (BA Portion)/Final Visit and 30 day safety follow-up; Vital Signs (blood pressure, heart rate, body temperature) will be done at all visits.
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Physical exam at Screening, Day 1 of Periods 1, 2 and 3 and Day 5, Period 2 (FE portion), Day 5, Period 3 (BA Portion)/Final Visit and 30 day safety follow-up; Vital Signs (blood pressure, heart rate, body temperature) will be done at all visits.
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Safety: Clinical Lab Tests will be performed for each participant as a safety measure.
Time Frame: Screening, Day 1, Periods 1 and 2, Day 5, Period 2 (FE portion), Day 5, Period 3 (BA portion)/Final Visit and 30 day safety follow-up.
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Chemistry, hematology, urinalysis lab tests
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Screening, Day 1, Periods 1 and 2, Day 5, Period 2 (FE portion), Day 5, Period 3 (BA portion)/Final Visit and 30 day safety follow-up.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (ACTUAL)
December 1, 2011
Study Completion (ACTUAL)
January 1, 2012
Study Registration Dates
First Submitted
October 11, 2011
First Submitted That Met QC Criteria
January 6, 2012
First Posted (ESTIMATE)
January 10, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
August 28, 2012
Last Update Submitted That Met QC Criteria
August 24, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M12-468
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced or Metastatic Solid Tumors
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-
Incendia TherapeuticsRecruitingAdvanced or Metastatic Solid TumorsUnited States
-
PharmAbcineMerck Sharp & Dohme LLC; Novotech (Australia) Pty LimitedNot yet recruitingAdvanced or Metastatic Solid TumorsAustralia
-
Jiangsu Simcere Pharmaceutical Co., Ltd.Completed
-
Taiho Oncology, Inc.TerminatedAdvanced or Metastatic Solid Tumors Irrespective of Gene Alterations | Advanced or Metastatic Solid Tumors With Germline PTEN Inactivating MutationsUnited States, United Kingdom, Austria, France
-
DynamiCure BiotechnologyRecruitingAdvanced or Metastatic Solid TumorsUnited States, Australia
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RecruitingAdvanced or Metastatic Solid TumorsChina
-
Shanghai Henlius BiotechActive, not recruitingAdvanced or Metastatic Solid TumorsAustralia
-
TakedaTakeda Development Center Americas, Inc.Active, not recruitingAdvanced or Metastatic Solid TumorsUnited States, China, Croatia, Japan, Latvia, Poland, Brazil, Lithuania, Switzerland
-
Ono Pharmaceutical Co. LtdActive, not recruitingAdvanced or Metastatic Solid TumorsJapan
Clinical Trials on linifanib
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AbbottTerminatedAdvanced Solid TumorsUnited States
-
AbbVieCompleted
-
AbbottCompletedAdvanced Solid TumorsUnited States
-
Vanderbilt-Ingram Cancer CenterTerminatedRecurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer | Stage IVB Colon Cancer | Stage IVB Rectal CancerUnited States
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BioGene Pharmaceutical Ltd.WithdrawnSafety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis (ELTA)Endometriosis | Endometriosis Ovary | Endometriosis, Rectum | Endometriosis ExternaSwitzerland
-
AbbVieCompleted
-
AbbottCompletedSolid TumorsUnited States
-
AbbottCompletedAdvanced Solid TumorsUnited States