Solid TumorsPhase 1NCT01114191
A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)
A Phase 1 study testing ABT-869 and ketoconazole in people with Solid Tumors, run by Abbott at 2 sites in United States.
Trial summary
This is a phase 1, open-label study designed to determine the interaction of ketoconazole with ABT-869. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- ABT-869 and ketoconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Feb 2011
- 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
- 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.
- 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
- Renal function: serum creatinine <= 2.0 mg/dL;
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- 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
- Must have PTT <= 1.5 x 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 90 days 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);
- Vasectomized male subjects or vasectomized partner of female subjects;
- Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration; if the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 1 month after study completion;
- Intrauterine device (IUD);
- Double barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or creams);
- Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 90 days following completion of therapy.
- Is capable of understanding and complying with parameters as outlined in the protocol and able to sign the informed consent, approved by an Independent Ethic 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 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.
- Has undergone major surgery within 21 days of Study Day 1.
- 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).
- Has a central thoracic tumor lesion as defined by location involving or abutting the hilar structures. The presence of central nodal disease is allowed.
- Female subjects who are pregnant or breastfeeding.
- Has received potential inhibitors of the metabolism of linifanib within 21 days prior to initial study drug administration. Such drugs include CYP3A inhibitors e.g., triazole, itraconazole, ketoconazole, fluconazole, grapefruit juice, verapamil, diltiazem, aprepitant, clarithromycin and erythromycin; CYP1A2 inhibitors e.g., fluvoxamine, ciprofloxacin, mexiletine, propafenone and zileuton; CYP2C19 inhibitors e.g., omeprazole; CYP2C8 substrates e.g., repaglinide, paclitaxel and rosiglitazone and CYP3A inducers e.g., rifampin and carbamazepine.
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- Has proteinuria defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade > 1 at baseline as measured by a urine dipstick (2+ or greater) and confirmed by a 24 hour urine collection (> 1 g/24 hrs). Subjects may be re-screened if proteinuria is shown to be controlled with or without intervention.
- Currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 100 mmHg; or systolic blood pressure (BP) > 150 mmHg. Subjects may be re-screened if BP is shown to be controlled with or without intervention.
- Clinically significant uncontrolled condition(s) including but not limited to:
- Active uncontrolled infection
- Class III or IV heart failure as defined by the New York Heart Association functional classification system
- Unstable angina pectoris or cardiac arrhythmia
- Myocardial infarction within last 6 months
- History of adrenal insufficiency
- History of cerebral vascular accident within last 6 months
- Active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption
- History of autoimmune disease with kidney involvement
- History of overt bleeding (> 30 mL bleeding/episode) within 3 months of study drug administration
- Psychiatric illness/social situation that would limit compliance with study requirements
- Any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
- Is receiving combination anti-retroviral therapy for human immunodeficiency virus (HIV).
- Has consumed grapefruit or grapefruit products within 21 days prior to initial study drug administration.
- Has a documented left ventricular (LV) ejection fraction < 50%.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site Reference ID/Investigator# 35784
Detroit, Michigan, 48201
Site Reference ID/Investigator# 36527
Lebanon, New Hampshire, 03756-0001
About this study
Official title: Ph I Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)
This is a phase 1, open-label study designed to determine the interaction of ketoconazole with ABT-869.
Read the detailed description
This study is designed to explore the drug interaction between ketoconazole and ABT-869 to determine the potential effect of ketoconazole on the metabolism of ABT-869. ABT-869 will be taken alone or in combination with ketoconazole. The safety of a single dose administration of ABT-869 when administered alone and in combination with ketoconazole will be assessed.
- Conditions
- Solid Tumors
- Being tested
- ABT-869, ketoconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-869Drug
Also called linifanib, ABT-869
2.5mg [5 mg days 1, 8 and 12. 17.5 mg on days 13 and after]
ketoconazoleDrug
400 mg days 6-11
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: ABT-869; Drug: ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effect of ketoconazole on the pharmacokinetics of ABT-869 in subjects with advanced or metastatic solid tumors.
Blood samples for the PK of ABT-869 and ketoconazole will be collected at designated time points throughout the study.
Measured: Different timepoints on Days 1-12
Secondary outcomes (1)
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
Adverse event monitoring, lab tests assessments, physical exam and vital signs will be evaluated throughout the study.
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark D McKee, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114191
- Sponsor's protocol ID
- M11-306
- Status last verified
- Jul 2011
- First submitted
- 29 Apr 2010
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ph I Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)
- ClinicalTrials.gov ID
- NCT01114191
- Acronym / sponsor ID
- M11-306
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 3 May 2010 (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.
This is a phase 1, open-label study designed to determine the interaction of ketoconazole with ABT-869.
Detailed description
This study is designed to explore the drug interaction between ketoconazole and ABT-869 to determine the potential effect of ketoconazole on the metabolism of ABT-869. ABT-869 will be taken alone or in combination with ketoconazole. The safety of a single dose administration of ABT-869 when administered alone and in combination with ketoconazole will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: ABT-869, Drug: ketoconazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female and age is >= 18 years.
- Must have a histologically or cytologically confirmed non-hematologic malignancy.
- 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 x ULN and/or INR <= 1.5.
Key exclusion criteria (23 listed)
- 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.
- Has undergone major surgery within 21 days of Study Day 1.
- 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).
- Has a central thoracic tumor lesion as defined by location involving or abutting the hilar structures. The presence of central nodal disease is allowed.
- Female subjects who are pregnant or breastfeeding.
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 |
|---|---|---|
| ABT-869Also: linifanib, ABT-8692.5mg [5 mg days 1, 8 and 12. 17.5 mg on days 13 and after] | Drug | Arm 1 |
| ketoconazole400 mg days 6-11 | Drug | Arm 1 |
Primary outcome
To investigate the effect of ketoconazole on the pharmacokinetics of ABT-869 in subjects with advanced or metastatic solid tumors.
Time frame: Different timepoints on Days 1-12
Blood samples for the PK of ABT-869 and ketoconazole will be collected at designated time points throughout the study.
1 secondary outcome
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
Time frame: Throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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 ABT-869 and ketoconazole in people with 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 16 inclusion and 23 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 26 Jul 2011. 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 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?
To investigate the effect of ketoconazole on the pharmacokinetics of ABT-869 in subjects with advanced or metastatic solid tumors. (time frame: Different timepoints on Days 1-12). 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 26 Jul 2011.