Solid TumorsPhase 1NCT02063230
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects
A Phase 1 study testing Selumetinib 50mg and Selumetinib 25mg in people with Solid Tumors, run by AstraZeneca at 1 site in United States.
Trial summary
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 130 yearsHealthy volunteers can take part
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Selumetinib 50mg and Selumetinib 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Nov 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 130 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be males or females (non-childbearing potential) aged 18 years or more and with a weight of at least 45 kg and a BMI between 18 and 40 kg/m2 inclusive.
- Subjects with stable liver cirrhosis and hepatic impairment for at least 3 months prior to the start of the study.
- Subjects must be in good health, as determined by a medical history, physical examination, 12-lead ECG, clinical laboratory evaluations, and an ophthalmic examination performed before the administration of the investigational product.
Who cannot join
- Subjects of Japanese or non-Japanese Asian ethnicity
- Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (eg, China, Taiwan, Korea, Philippines, Thailand, Vietnam, and Malaysia). Asian Indians are acceptable.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the investigational product
- Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day.
- Undergone liver transplantation. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Comparative Study to Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib (AZD6244, ARRY-142886) (Hyd-Sulfate) Following Single Oral Dosing to Healthy Subjects and to Subjects With Mild, Moderate, and Severe Hepatic Impairment
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
Read the detailed description
An open label study to assess the pharmcokinetics, safety and tolerability of a single dose of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
- Conditions
- Solid Tumors
- Being tested
- Selumetinib 50mg, Selumetinib 25mg
- Keywords
- Phase I, healthy, pharmacokinetic, hepatic impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selumetinib 50mgDrug
HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1
Selumetinib 25mgDrug
Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Selumetinib HV | Experimental | Healthy volunteers (HV) Receives: Drug: Selumetinib 50mg |
| Selumetinib mild impairment | Experimental | Mild (Child Pugh A) hepatic impaired patients Receives: Drug: Selumetinib 50mg |
| Selumetinib moderate impairment | Experimental | Moderate (Child Pugh B) hepatic impaired patients Receives: Drug: Selumetinib 50mg |
| Selumetinib severe impairment | Experimental | Severe (Child Pugh C) hepatic impairment patients Receives: Drug: Selumetinib 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (0 to Infinity) of Total Selumetinib
Measured: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Cmax of Total Selumetinib
Measured: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Dose Normalized AUC, Total Selumetinib
Measured: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Dose Normalized Cmax, Total Selumetinib
Measured: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Dose Normalized AUC, Unbound Selumetinib
Measured: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Dose Normalized Cmax, Unbound Selumetinib
Measured: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas C Marbury, MD, Principal investigator, Orlando Clinical Research Center, 5055 S Orange Avenue, Orlando, Florida, United States.Ian Smith, MD, Study director, Astrazeneca, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063230
- Sponsor's protocol ID
- D1532C00082
- Status last verified
- Jun 2016
- First submitted
- 13 Feb 2014
- Last updated
- 21 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Comparative Study to Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib (AZD6244, ARRY-142886) (Hyd-Sulfate) Following Single Oral Dosing to Healthy Subjects and to Subjects With Mild, Moderate, and Severe Hepatic Impairment
- ClinicalTrials.gov ID
- NCT02063230
- Acronym / sponsor ID
- D1532C00082
- Conditions
- Solid Tumors
- Keywords
- Phase I, healthy, pharmacokinetic, hepatic impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Posted 2 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
Detailed description
An open label study to assess the pharmcokinetics, safety and tolerability of a single dose of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Selumetinib HV | Experimental | Drug: Selumetinib 50mgHealthy volunteers (HV) |
| Selumetinib mild impairment | Experimental | Drug: Selumetinib 50mgMild (Child Pugh A) hepatic impaired patients |
| Selumetinib moderate impairment | Experimental | Drug: Selumetinib 50mgModerate (Child Pugh B) hepatic impaired patients |
| Selumetinib severe impairment | Experimental | Drug: Selumetinib 25mgSevere (Child Pugh C) hepatic impairment patients |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will be males or females (non-childbearing potential) aged 18 years or more and with a weight of at least 45 kg and a BMI between 18 and 40 kg/m2 inclusive.
- Subjects with stable liver cirrhosis and hepatic impairment for at least 3 months prior to the start of the study.
- Subjects must be in good health, as determined by a medical history, physical examination, 12-lead ECG, clinical laboratory evaluations, and an ophthalmic examination performed before the administration of the investigational product.
Key exclusion criteria (5 listed)
- Subjects of Japanese or non-Japanese Asian ethnicity
- Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (eg, China, Taiwan, Korea, Philippines, Thailand, Vietnam, and Malaysia). Asian Indians are acceptable.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the investigational product
- Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day.
- Undergone liver transplantation. -
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 |
|---|---|---|
| Selumetinib 50mgHV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1 | Drug | Selumetinib HV, Selumetinib mild impairment, Selumetinib moderate impairment |
| Selumetinib 25mgSevere (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1 | Drug | Selumetinib severe impairment |
Primary outcome
AUC (0 to Infinity) of Total Selumetinib
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Cmax of Total Selumetinib
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Dose Normalized AUC, Total Selumetinib
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Dose Normalized Cmax, Total Selumetinib
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Dose Normalized AUC, Unbound Selumetinib
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Dose Normalized Cmax, Unbound Selumetinib
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Solid Tumors
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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
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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
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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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.
Thomas C Marbury, MD principal investigator
Orlando Clinical Research Center, 5055 S Orange Avenue, Orlando, Florida, United States.
Ian Smith, MD study director
Astrazeneca, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Selumetinib 50mg and Selumetinib 25mg in people with Solid Tumors, run by AstraZeneca at 1 site 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 3 inclusion and 5 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 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 2 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AUC (0 to Infinity) of Total Selumetinib (time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose). The study lists 6 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 Jul 2016.