NCT01605916

Brief Summary

The objective of this study will be to investigate the safety and tolerability of AZD6244 given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following the combination regimen dose escalation phase (Part A) of the study additional patients may be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability, pharmacokinetics and biological activity of the combination in this patient population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2012

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

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

May 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 14, 2016

Completed
Last Updated

October 21, 2016

Status Verified

September 1, 2016

Enrollment Period

2.8 years

First QC Date

May 21, 2012

Results QC Date

April 6, 2016

Last Update Submit

September 8, 2016

Conditions

Neoplasms,Metastatic Cancer,Non-Small Cell Lung CancerAdvanced Solid Malignancies

Keywords

Cancer,Tumour,Metastatic,Lung cancer,Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (12)

  • Cmax of Selumetinib After Single Dose

    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib

    Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose

  • Tmax of Selumetinib After Single Dose

    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib

    Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose

  • AUC(0-12) of Selumetinib After Single Dose

    Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dosey) of Selumetinib following single oral dose of Selumetinib

    Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

  • Cmax of N-desmethyl Selumetinib After Single Dose

    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib

    Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose

  • Tmax of N-desmethyl Selumetinib After Single Dose

    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib

    Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose

  • AUC(0-12) of N-desmethyl Selumetinib After Single Dose

    Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib following single oral dose of Selumetinib

    Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

  • Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib

    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib

    Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

  • Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib

    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib

    Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

  • AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib

    Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of Selumetinib during oral twice daily dose of Selumetinib

    Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

  • Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib

    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib

    Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

  • Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib

    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib

    Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

  • AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib

    Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib

    Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Secondary Outcomes (3)

  • Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2

    Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

  • Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2

    Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

  • AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2

    Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Study Arms (5)

Selumetinib (AZD6244) 25 mg

EXPERIMENTAL

monotherapy

Drug: AZD6244

Selumetinib (AZD6244) 50 mg

EXPERIMENTAL

monotherapy

Drug: AZD6244

Selumetinib (AZD6244) 75 mg

EXPERIMENTAL

monotherapy

Drug: AZD6244

Selumetinib (AZD6244) 75 mg + Doce

EXPERIMENTAL

Combination

Drug: AZD6244

Selumetinib (AZD6244) 25 mg + Doce

EXPERIMENTAL

combination

Drug: AZD6244

Interventions

AZD6244DRUG

Tablet Oral bid

Also known as: Selumetinib (AZD6244)
Selumetinib (AZD6244) 25 mgSelumetinib (AZD6244) 25 mg + DoceSelumetinib (AZD6244) 50 mgSelumetinib (AZD6244) 75 mgSelumetinib (AZD6244) 75 mg + Doce

Eligibility Criteria

Age20 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with lung cancer who have not responded to prior therapy or have become worse.
  • Patients who have overall good general conditions.
  • Patients who have at least one lesion that can be accurately assessed by imaging.
  • Patients who have appropriate renal conditions confirmed by test results for taking part in the study.
  • Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.

You may not qualify if:

  • Patients with brain metastases or spinal cord compression.
  • Patients with significant abnormal ECG findings.
  • Patients with evidence of severe or uncontrolled systemic disease.
  • The main organ functional test values for bone marrow, kidney, and liver, etc., do not meet the standards.
  • Patients with known hypersensitivity to docetaxel or products containing polysorbate 80.
  • Only for monotherapy cohort eligibility criteria Patients with advanced solid malignancies refractory to standard treatment or for which no standard therapy exists irrespective of the stage and previous treatment.
  • Patients with histologically or cytologically confirmed advanced solid malignancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Fukuoka, Japan

Location

Research Site

Kashiwa-shi, Japan

Location

Research Site

Nagoya, Japan

Location

MeSH Terms

Conditions

NeoplasmsNeoplasm MetastasisCarcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

AZD 6244

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Masahiro Nii
Organization
Biometrics Department, Science Affairs Division, R&D, Astrazeneca Japan
Masahiro.Nii@astrazeneca.com

Study Officials

  • Ian Smith, Medical Science Director

    AstraZeneca

    STUDY DIRECTOR

  • Yuichiro Ohe, Medical Doctor

    National Cancer Centre East

    PRINCIPAL INVESTIGATOR

  • Hideo Saka, Medical Doctor

    National Hospital Organisation Nagoya Medical Centre

    PRINCIPAL INVESTIGATOR

  • Takashi Seto, Medical Doctor

    National Hospital Organization Kyushu Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 25, 2012

Study Start

June 1, 2012

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

October 21, 2016

Results First Posted

July 14, 2016

Record last verified: 2016-09

Locations

JP(3)