NCT02063230

Brief Summary

A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 2, 2015

Completed
Last Updated

July 21, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

February 13, 2014

Results QC Date

October 5, 2015

Last Update Submit

June 21, 2016

Conditions

Solid Tumors

Keywords

Phase I, healthy, pharmacokinetic, hepatic impairment

Outcome Measures

Primary Outcomes (6)

  • AUC (0 to Infinity) of Total Selumetinib

    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

    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

    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

    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

    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

    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

Study Arms (4)

Selumetinib HV

EXPERIMENTAL

Healthy volunteers (HV)

Drug: Selumetinib 50mg

Selumetinib mild impairment

EXPERIMENTAL

Mild (Child Pugh A) hepatic impaired patients

Drug: Selumetinib 50mg

Selumetinib moderate impairment

EXPERIMENTAL

Moderate (Child Pugh B) hepatic impaired patients

Drug: Selumetinib 50mg

Selumetinib severe impairment

EXPERIMENTAL

Severe (Child Pugh C) hepatic impairment patients

Drug: Selumetinib 25mg

Interventions

Selumetinib 50mgDRUG

HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1

Selumetinib HVSelumetinib mild impairmentSelumetinib moderate impairment
Selumetinib 25mgDRUG

Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1

Selumetinib severe impairment

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Orlando, Florida, United States

Location

MeSH Terms

Interventions

AZD 6244

Limitations and Caveats

In the moderate group, 2 patients received Selumetinib 25mg and are not included in sumaries for AUC and Cmax. Dose normalized parameters are more appropriate for comparisons between groups and are included for all subjects.

Results Point of Contact

Title
Gabriella Mariani
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com
+44 7818 523 899

Study Officials

  • Thomas C Marbury, MD

    Orlando Clinical Research Center, 5055 S Orange Avenue, Orlando, Florida, United States.

    PRINCIPAL INVESTIGATOR

  • Ian Smith, MD

    Astrazeneca, UK

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 14, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

July 21, 2016

Results First Posted

November 2, 2015

Record last verified: 2016-06

Locations

US(1)