Solid TumoursPhase 1NCT02056392

To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers

A Phase 1 study testing Selumetinib and Moxifloxacin in people with Solid Tumours, run by AstraZeneca at 1 site in United States.

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

Study to assess the effect of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc interval in healthy male volunteers. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Solid Tumours
What is being tested?: Selumetinib and Moxifloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteUnited States
Study dates: Mar 2014to Aug 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 45 years
Men only
Healthy volunteers accepted
Adult

Inclusion Criteria: 1. Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg (inclusive). 2. Must have not smoked in the last 30 days prior to screening for this study. 3. Have a calculated creatinine clearance (CrCL) greater than 50 mL/min using the Cockcroft-Gault formula.

Exclusion Criteria: 1. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Subjects where any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (e.g. China, Taiwan, Korea, Philippines, Thailand, Vietnam, and Malaysia). Asian Indians are acceptable. 3. Past history of central serous retinopathy or retinal vein thrombosis,intraocular pressure greater than 21 mmHg or uncontrolled glaucoma. 4. Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs or ECG at baseline in the opinion of the investigator. 5. History or presence of any clinically significant disease or disorder in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Overland Park, Kansas

Other trials in United States

About this study

Official title: A Phase I, Double-blind (Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), Placebo-controlled, Open-Label (Moxifloxacin) Positive-controlled, Randomized, Three-period Crossover Study to Assess the Effects of Single Oral Dose of Selumetinib (75 mg) on QTc Interval Compared to Placebo, Using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers Aged 18 to 45 Years

Study to assess the effect of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc interval in healthy male volunteers.

Read the detailed description

A double-blind (Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), Placebo-controlled, Open-Label (Moxifloxacin) Positive-controlled, Randomized, Three-period Crossover Study to Assess the Effects of Single Oral Dose of Selumetinib (75 mg) on QTc Interval Compared to Placebo, using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers

Conditions: Solid Tumours
Being tested: Selumetinib, Moxifloxacin, selumetinib placebo
Keywords: Phase I, healthy, pharmacokinetics

What participants receive

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

SelumetinibDrug
Also called AZD6244
Volunteers will receive 75 mg selumetinib oral dose (Treatment A)
MoxifloxacinDrug
Also called Avelox®
Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B)
selumetinib placeboDrug
Also called AZD6244 placebo
Volunteers will receive selumetinib placebo oral dose (Treatment C)

Study groups in NCT02056392
Study group	Role	What they receive
Selumetinib 75mg	Experimental	Volunteers will receive selumetinib 75mg administered by mouth, as a capsule Receives: Drug: Selumetinib
Moxifloxacin 400 mg	Active comparator	Volunteers will receive moxifloxacin 400mg administered by mouth, as a capsule Receives: Drug: Moxifloxacin
Selumetinib 75mg placebo	Placebo comparator	Volunteers will receive selumetinib 75mg placebo, administered by mouth, as a capsule. Receives: Drug: selumetinib placebo

What is being measured

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

Change From Baseline in QTcF
Change from baseline in QTcF at 30 minutes (msec)
Measured: 30 min
Change From Baseline in QTcF
Change from baseline in QTcF at 1 hour (msec)
Measured: 1 hour
Change From Baseline in QTcF
Change from baseline in QTcF at 1 hour 30 min (msec)
Measured: 1 hour 30 min
Change From Baseline in QTcF
Change from baseline in QTcF at 2 hours (msec)
Measured: 2 hours
Change From Baseline in QTcF
Change from baseline in QTcF at 3 hours (msec)
Measured: 3 hours
Change From Baseline in QTcF
Change from baseline in QTcF at 4 hours (msec)
Measured: 4 hours
Change From Baseline in QTcF
Change from baseline in QTcF at 6 hours (msec)
Measured: 6 hours
Change From Baseline in QTcF
Change from baseline in QTcF at 8 hours (msec)
Measured: 8 hours
Change From Baseline in QTcF
Change from baseline in QTcF at 12 hours (msec)
Measured: 12 hours
Change From Baseline in QTcF
Change from baseline in QTcF at 24 hours (msec)
Measured: 24 hours

Timeline

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

Mar 2014Aug 2014

First posted6 Feb 2014 (estimated)
Study startMar 2014
Primary completionAug 2014
Study completionAug 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 TumoursStudies 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: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02056392
Sponsor's protocol ID: D1532C00071
Status last verified: Sep 2015
First submitted: 5 Feb 2014
Last updated: 9 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Solid Tumours trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Double-blind (Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), Placebo-controlled, Open-Label (Moxifloxacin) Positive-controlled, Randomized, Three-period Crossover Study to Assess the Effects of Single Oral Dose of Selumetinib (75 mg) on QTc Interval Compared to Placebo, Using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers Aged 18 to 45 Years
ClinicalTrials.gov ID: NCT02056392
Acronym / sponsor ID: D1532C00071
Conditions: Solid Tumours
Keywords: Phase I, healthy, pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 6 Feb 2014 (estimated)
Results: Posted 9 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study to assess the effect of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc interval in healthy male volunteers.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Selumetinib 75mg	Experimental	Drug: SelumetinibVolunteers will receive selumetinib 75mg administered by mouth, as a capsule
Moxifloxacin 400 mg	Active comparator	Drug: MoxifloxacinVolunteers will receive moxifloxacin 400mg administered by mouth, as a capsule
Selumetinib 75mg placebo	Placebo comparator	Drug: selumetinib placeboVolunteers will receive selumetinib 75mg placebo, administered by mouth, as a capsule.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

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
SelumetinibAlso: AZD6244Volunteers will receive 75 mg selumetinib oral dose (Treatment A)	Drug	Selumetinib 75mg
MoxifloxacinAlso: Avelox®Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B)	Drug	Moxifloxacin 400 mg
selumetinib placeboAlso: AZD6244 placeboVolunteers will receive selumetinib placebo oral dose (Treatment C)	Drug	Selumetinib 75mg placebo

Primary outcome

Change From Baseline in QTcF
Time frame: 30 min
Change from baseline in QTcF at 30 minutes (msec)
Change From Baseline in QTcF
Time frame: 1 hour
Change from baseline in QTcF at 1 hour (msec)
Change From Baseline in QTcF
Time frame: 1 hour 30 min
Change from baseline in QTcF at 1 hour 30 min (msec)
Change From Baseline in QTcF
Time frame: 2 hours
Change from baseline in QTcF at 2 hours (msec)
Change From Baseline in QTcF
Time frame: 3 hours
Change from baseline in QTcF at 3 hours (msec)
Change From Baseline in QTcF
Time frame: 4 hours
Change from baseline in QTcF at 4 hours (msec)
Change From Baseline in QTcF
Time frame: 6 hours
Change from baseline in QTcF at 6 hours (msec)
Change From Baseline in QTcF
Time frame: 8 hours
Change from baseline in QTcF at 8 hours (msec)
Change From Baseline in QTcF
Time frame: 12 hours
Change from baseline in QTcF at 12 hours (msec)
Change From Baseline in QTcF
Time frame: 24 hours
Change from baseline in QTcF at 24 hours (msec)

Results and safety

Results posted to the registry on 9 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Selumetinib/Moxifloxacin/Selumetinib Placebo	10	8
Moxifloxacin/Selumetinib/Selumetinib Placebo	9	8
Moxifloxacin/Selumetinib Placebo/Selumetinib	9	6
Selumetinib Placebo/Moxifloxacin/Selumetinib	9	9
Selumetinib Placebo/Selumetinib/Moxifloxacin	8	7
Selumetinib/Selumetinib Placebo/Moxifloxacin	9	9

Primary outcome: Change From Baseline in QTcF

Time frame: 30 min. Least squares mean (95% Confidence Interval). Unit: msec

Measure	Moxifloxacin n = 50	Placebo n = 49	Selumetinib n = 50
Value	2.0 (0.5 to 3.5)	-4.1 (-5.6 to -2.5)	-4.2 (-5.7 to -2.7)

Placebo vs Selumetinib: Mean Difference (Final Values): -0.2 (90% CI -1.8 to 1.5), Mixed Models Analysis
Moxifloxacin vs Placebo: Mean Difference (Final Values): 6.1 (90% CI 4.4 to 7.7), Mixed Models Analysis

Population analysed: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Primary outcome: Change From Baseline in QTcF

Time frame: 1 hour. Least squares mean (95% Confidence Interval). Unit: msec

Measure	Moxifloxacin n = 50	Placebo n = 49	Selumetinib n = 50
Value	7.9 (6.4 to 9.4)	-1.4 (-2.9 to 0.2)	-1.7 (-3.2 to -0.2)

Placebo vs Selumetinib: Mean Difference (Final Values): -0.4 (90% CI -2.0 to 1.3), Mixed Models Analysis
Moxifloxacin vs Placebo: Mean Difference (Final Values): 9.2 (90% CI 7.6 to 10.8), Mixed Models Analysis

Population analysed: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Primary outcome: Change From Baseline in QTcF

Time frame: 1 hour 30 min. Least squares mean (95% Confidence Interval). Unit: msec

Measure	Moxifloxacin n = 50	Placebo n = 49	Selumetinib n = 50
Value	8.1 (6.6 to 9.6)	-1.8 (-3.3 to -0.2)	-0.9 (-2.4 to 0.6)

Placebo vs Selumetinib: Mean Difference (Final Values): 0.9 (90% CI -0.7 to 2.5), Mixed Models Analysis
Moxifloxacin vs Placebo: Mean Difference (Final Values): 9.9 (90% CI 8.3 to 11.5), Mixed Models Analysis

Population analysed: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Primary outcome: Change From Baseline in QTcF

Time frame: 2 hours. Least squares mean (95% Confidence Interval). Unit: msec

Measure	Moxifloxacin n = 50	Placebo n = 49	Selumetinib n = 50
Value	7.9 (6.4 to 9.4)	-2.3 (-3.8 to -0.7)	-1.9 (-3.4 to -0.4)

Placebo vs Selumetinib: Mean Difference (Final Values): 0.4 (90% CI -1.2 to 2.0), Mixed Models Analysis
Moxifloxacin: Mean Difference (Final Values): 10.1 (90% CI 8.5 to 11.8), Mixed Models Analysis

Population analysed: All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set

Adverse events

Time frame: AEs were collected for up to 5 weeks, this was from the day before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Selumetinib	0 of 51 (0%)	5 of 51 (9.8%)	Not reported
Moxifloxacin	0 of 51 (0%)	5 of 51 (9.8%)	Not reported
Placebo	1 of 50 (2%)	4 of 50 (8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Solid Tumours

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.

Scott Rasmussen, MD principal investigator

Quintiles 6700 W 115th Street, Kansas, US

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 and Moxifloxacin in people with Solid Tumours, 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?

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 9 Nov 2015. 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. Some participants in this study may receive a placebo. 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 9 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?

Change From Baseline in QTcF (time frame: 30 min). The study lists 10 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 NCT02056392.

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 9 Nov 2015.