Advanced Solid TumorsPhase 1NCT01286974
A Pharmacokinetic Study to Access How the Body Absorbs and Removes Linifanib in Male Patients With Advanced Solid Tumors.
A Phase 1 study testing [14C]linifanib and ABT-869, linifanib in people with Advanced Solid Tumors, run by Abbott at 2 sites in United States.
Trial summary
A pharmacokinetic study to access how the body absorbs and removes linifanib in male patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- [14C]linifanib and ABT-869, linifanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Sep 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be >/= 18 years of age.
- Subject must have a histologically or cytologically confirmed non-hematologic malignancy.
- Eastern cooperative Oncology Group (ECOG) Performance Score of 0 to 2.
- Subject must have adequate bone marrow, renal and hepatic function.
- Subject must have Partial Thromboplastin Time (PTT) </= 1.5 x Upper Limit of Normal (ULN) and International Normalized Ratio (INR) </= 1.5.
- Subject must be capable of understanding and complying with parameters as outlined in the protocol and able to sign the informed consent.
Who cannot join
- Subject has received previous administration of a radiolabeled research substance within 12 months prior to Study Day 1 or exposure to significant radiation (e.g., barium meal, etc.) within the past 3 months or within a period defined by 5 half-lives, whichever is shorter, prior to Study Day 1.
- Subject has received anti-cancer therapy including investigational agents, cytotoxic chemotherapy, radiation, hormonal or biologic therapy within 21 days or within a period defined by 5 half-lives, whichever is shorter, prior to Study Day 1.
- Subject is currently using a known inhibitor (e.g., ketoconazole) or inducer (e.g., rifampin) of cytochrome P450 3A (CYP3A) within 1 month prior to Study Day 1.
- 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 Study Day 1.
- The subject has brain or meningeal metastases.
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- The subject has non-small cell lung cancer (NSCLC) with a predominant squamous cell histology.
- Subject is receiving therapeutic anticoagulation therapy.
- Subject has a history of/or currently exhibits clinically significant events of bleeding (e.g., hemoptysis).
- Subject has proteinuria Common Terminology Criteria (CTC) Grade > 2 at baseline.
- Subject currently exhibits symptomatic or persistent, uncontrolled hypertension.
- Subject has a history of myocardial infarction within 6 months.
- Subject has known autoimmune disease with renal involvement.
- Subject is receiving combination anti-retroviral therapy for human immunodeficiency virus (HIV).
- Clinically significant uncontrolled conditions/medical symptoms.
- Subject has a documented left ventricular (LV) ejection fraction < 50%.
- Subject has previously received linifanib.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site Reference ID/Investigator# 40942
Cleveland, Ohio, 44195
Site Reference ID/Investigator# 53663
Cleveland, Ohio, 44195
About this study
Official title: Disposition of [14C]ABT-869 in Patients With Solid Tumors Following a Single Oral Dose Administration
A pharmacokinetic study to access how the body absorbs and removes linifanib in male patients with advanced solid tumors.
Read the detailed description
This study is designed to assess the mass balance of [14C]linifanib and the metabolic profiles of linifanib in 4 subjects with advanced solid tumors following a single oral dose. Subjects may continue on linifanib after completion of the metabolism study. The results of this study will determine the exposure of major metabolites and excretion pathway(s) of the parent drug and metabolites of linifanib in humans.
- Conditions
- Advanced Solid Tumors
- Being tested
- [14C]linifanib, ABT-869, linifanib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]linifanibDrug
[14C]linifanib, single administration, oral liquid
ABT-869, linifanibDrug
linifanib once a day (QD), oral tablet
| Study group | Role | What they receive |
|---|---|---|
| ADME | Experimental | [14C]linifanib Receives: Drug: [14C]linifanib |
| Extension | Experimental | linifanib Receives: Drug: ABT-869, linifanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Profile
Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points.
Measured: Various timepoints from Day 1 through approximately Day 9
Total radioactivity
Blood, urine, and fecal samples for total radioactivity analysis will be collected at designated time points.
Measured: Various timepoints from Day 1 through approximately Day 9
Secondary outcomes (1)
Safety (Number of subjects with adverse events and/or dose-limiting toxicities)
Adverse event monitoring, lab test assessments, physical exam and vital signs will be evaluated throughout the study.
Measured: At each treatment visit (daily for first 9 days and then approximately every 4 weeks through end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionSep 2012
Why it stopped: Terminated early, Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark D. McKee, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286974
- Sponsor's protocol ID
- M10-966
- Status last verified
- Sep 2012
- First submitted
- 28 Jan 2011
- Last updated
- 21 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposition of [14C]ABT-869 in Patients With Solid Tumors Following a Single Oral Dose Administration
- ClinicalTrials.gov ID
- NCT01286974
- Acronym / sponsor ID
- M10-966
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early, Sponsor Decision
- Enrolment
- 3 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pharmacokinetic study to access how the body absorbs and removes linifanib in male patients with advanced solid tumors.
Detailed description
This study is designed to assess the mass balance of [14C]linifanib and the metabolic profiles of linifanib in 4 subjects with advanced solid tumors following a single oral dose. Subjects may continue on linifanib after completion of the metabolism study. The results of this study will determine the exposure of major metabolites and excretion pathway(s) of the parent drug and metabolites of linifanib in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADME | Experimental | Drug: [14C]linifanib[14C]linifanib |
| Extension | Experimental | Drug: ABT-869, linifaniblinifanib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be >/= 18 years of age.
- Subject must have a histologically or cytologically confirmed non-hematologic malignancy.
- Eastern cooperative Oncology Group (ECOG) Performance Score of 0 to 2.
- Subject must have adequate bone marrow, renal and hepatic function.
- Subject must have Partial Thromboplastin Time (PTT) </= 1.5 x Upper Limit of Normal (ULN) and International Normalized Ratio (INR) </= 1.5.
Key exclusion criteria (17 listed)
- Subject has received previous administration of a radiolabeled research substance within 12 months prior to Study Day 1 or exposure to significant radiation (e.g., barium meal, etc.) within the past 3 months or within a period defined by 5 half-lives, whichever is shorter, prior to Study Day 1.
- Subject has received anti-cancer therapy including investigational agents, cytotoxic chemotherapy, radiation, hormonal or biologic therapy within 21 days or within a period defined by 5 half-lives, whichever is shorter, prior to Study Day 1.
- Subject is currently using a known inhibitor (e.g., ketoconazole) or inducer (e.g., rifampin) of cytochrome P450 3A (CYP3A) within 1 month prior to Study Day 1.
- 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 Study Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]linifanib[14C]linifanib, single administration, oral liquid | Drug | ADME |
| ABT-869, linifaniblinifanib once a day (QD), oral tablet | Drug | Extension |
Primary outcome
Pharmacokinetic Profile
Time frame: Various timepoints from Day 1 through approximately Day 9
Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points.
Total radioactivity
Time frame: Various timepoints from Day 1 through approximately Day 9
Blood, urine, and fecal samples for total radioactivity analysis will be collected at designated time points.
1 secondary outcome
Safety (Number of subjects with adverse events and/or dose-limiting toxicities)
Time frame: At each treatment visit (daily for first 9 days and then approximately every 4 weeks through end of treatment)
Results and safety
The study was stopped early (reason given: Terminated early, Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D. McKee, MD study director
Abbott
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]linifanib and ABT-869, linifanib in people with Advanced Solid Tumors, run by Abbott at 2 sites in United States.
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 6 inclusion and 17 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: stopped early, as of the sponsor's last update on 21 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Terminated early, Sponsor Decision). Results are not available in the source record.
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 Profile (time frame: Various timepoints from Day 1 through approximately Day 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2012.