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Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01605916
First received: May 21, 2012
Last updated: September 8, 2016
Last verified: September 2016
Results First Received: April 6, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Neoplasms,
Metastatic Cancer,
Non-Small Cell Lung Cancer
Advanced Solid Malignancies
Intervention: Drug: AZD6244

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled on 01 June 2012. Last subject last visit on 30 March 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 33 enrolled subjects, 25 subjects were assigned to selumetinib (AZD6244, ARRY-142886), and 8 subjects were not assigned. The reasons of no assignment were 'Screen failure' (7 subjects) and 'Withdrawal by subject' (1 subject).

Reporting Groups
  Description
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
Monotherapy Cohort 1 Selumetinib 25 mg Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
Monotherapy Cohort 2 Selumetinib 50 mg Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
Monotherapy Cohort 3 Selumetinib 75 mg Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies

Participant Flow:   Overall Study
    Combination Therapy Cohort 1 Selumetinib 75 mg + Doce   Combination Therapy Cohort 2 Selumetinib 25 mg + Doce   Monotherapy Cohort 1 Selumetinib 25 mg   Monotherapy Cohort 2 Selumetinib 50 mg   Monotherapy Cohort 3 Selumetinib 75 mg
STARTED   4   4   4   6   7 
COMPLETED   0   0   1 [1]   0   1 [1] 
NOT COMPLETED   4   4   3   6   6 
Adverse Event                1                0                0                1                0 
Lack of Efficacy                2                3                3                5                4 
Withdrawal by Subject                1                1                0                0                2 
[1] Subject ongoing the study at data cut off



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received selumetinib were included into the baseline analysis population.

Reporting Groups
  Description
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
Monotherapy Cohort 1 Selumetinib 25 mg Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
Monotherapy Cohort 2 Selumetinib 50 mg Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
Monotherapy Cohort 3 Selumetinib 75 mg Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
Total Total of all reporting groups

Baseline Measures
   Combination Therapy Cohort 1 Selumetinib 75 mg + Doce   Combination Therapy Cohort 2 Selumetinib 25 mg + Doce   Monotherapy Cohort 1 Selumetinib 25 mg   Monotherapy Cohort 2 Selumetinib 50 mg   Monotherapy Cohort 3 Selumetinib 75 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   4   4   6   7   25 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.5  (17.33)   58.8  (8.50)   60.0  (12.36)   60.0  (11.75)   66.7  (12.22)   61.0  (12.15) 
Gender 
[Units: Participants]
           
Female   1   1   2   1   4   9 
Male   3   3   2   5   3   16 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cmax of Selumetinib After Single Dose   [ Time Frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose ]

2.  Primary:   Tmax of Selumetinib After Single Dose   [ Time Frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose ]

3.  Primary:   AUC(0-12) of Selumetinib After Single Dose   [ Time Frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose ]

4.  Primary:   Cmax of N-desmethyl Selumetinib After Single Dose   [ Time Frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose ]

5.  Primary:   Tmax of N-desmethyl Selumetinib After Single Dose   [ Time Frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose ]

6.  Primary:   AUC(0-12) of N-desmethyl Selumetinib After Single Dose   [ Time Frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose ]

7.  Primary:   Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib   [ Time Frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose ]

8.  Primary:   Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib   [ Time Frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose ]

9.  Primary:   AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib   [ Time Frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose ]

10.  Primary:   Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib   [ Time Frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose ]

11.  Primary:   Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib   [ Time Frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose ]

12.  Primary:   AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib   [ Time Frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose ]

13.  Secondary:   Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2   [ Time Frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose ]

14.  Secondary:   Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2   [ Time Frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose ]

15.  Secondary:   AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2   [ Time Frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Masahiro Nii
Organization: Biometrics Department, Science Affairs Division, R&D, Astrazeneca Japan
e-mail: Masahiro.Nii@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01605916     History of Changes
Other Study ID Numbers: D1532C00067
Study First Received: May 21, 2012
Results First Received: April 6, 2016
Last Updated: September 8, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency