Back to resultsInvestigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer
Primary Purpose
Neoplasms,, Metastatic Cancer,, Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
AZD6244
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms, focused on measuring Cancer,, Tumour,, Metastatic,, Lung cancer,, Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Selumetinib (AZD6244) 25 mg
Selumetinib (AZD6244) 50 mg
Selumetinib (AZD6244) 75 mg
Selumetinib (AZD6244) 75 mg + Doce
Selumetinib (AZD6244) 25 mg + Doce
Arm Description
monotherapy
monotherapy
monotherapy
Combination
combination
Outcomes
Primary Outcome Measures
Cmax of Selumetinib After Single Dose
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
Tmax of Selumetinib After Single Dose
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
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
Cmax of N-desmethyl Selumetinib After Single Dose
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib
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
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
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
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
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
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
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
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
Secondary Outcome Measures
Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01605916
Brief Title
Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer
Official Title
A Phase I, Open-Label Study to Investigate the Safety and Tolerability of AZD6244 (Selumetinib) When Given as a Monotherapy in Japanese Patients With Advanced Solid Malignancies, and When Given in Combination With Docetaxel as 2nd Line Therapy in Japanese Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
Detailed Description
The objective of the combination therapy part of this study will be to investigate the safety and tolerability of AZD6244 given in combination with docetaxel as 2nd line therapy in Japanese patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV). In addition, the pharmacokinetic profile of AZD6244 and docetaxel will be investigated.
The objective of the monotherapy part of this study will be to investigate the safety and tolerability of AZD6244 given as a monotherapy in Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile of monotherapy AZD6244 will be investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms,, Metastatic Cancer,, Non-Small Cell Lung Cancer, Advanced Solid Malignancies
Keywords
Cancer,, Tumour,, Metastatic,, Lung cancer,, Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Selumetinib (AZD6244) 25 mg
Arm Type
Experimental
Arm Description
monotherapy
Arm Title
Selumetinib (AZD6244) 50 mg
Arm Type
Experimental
Arm Description
monotherapy
Arm Title
Selumetinib (AZD6244) 75 mg
Arm Type
Experimental
Arm Description
monotherapy
Arm Title
Selumetinib (AZD6244) 75 mg + Doce
Arm Type
Experimental
Arm Description
Combination
Arm Title
Selumetinib (AZD6244) 25 mg + Doce
Arm Type
Experimental
Arm Description
combination
Intervention Type
Drug
Intervention Name(s)
AZD6244
Other Intervention Name(s)
Selumetinib (AZD6244)
Intervention Description
Tablet Oral bid
Primary Outcome Measure Information:
Title
Cmax of Selumetinib After Single Dose
Description
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
Time Frame
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
Title
Tmax of Selumetinib After Single Dose
Description
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
Time Frame
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
Title
AUC(0-12) of Selumetinib After Single Dose
Description
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
Time Frame
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Title
Cmax of N-desmethyl Selumetinib After Single Dose
Description
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib
Time Frame
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
Title
Tmax of N-desmethyl Selumetinib After Single Dose
Description
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib
Time Frame
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
Title
AUC(0-12) of N-desmethyl Selumetinib After Single Dose
Description
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
Time Frame
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Title
Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib
Description
Pharmacokinetic parameter (Cmax: maximum plasma concentration) 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
Title
Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib
Description
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) 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
Title
AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib
Description
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
Time Frame
Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Title
Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
Description
Pharmacokinetic parameter (Cmax: maximum plasma concentration) 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
Title
Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
Description
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) 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
Title
AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
Description
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
Time Frame
Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Secondary Outcome Measure Information:
Title
Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Description
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
Time Frame
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Title
Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Description
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
Time Frame
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Title
AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Description
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
Time Frame
Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Smith, Medical Science Director
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yuichiro Ohe, Medical Doctor
Organizational Affiliation
National Cancer Centre East
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hideo Saka, Medical Doctor
Organizational Affiliation
National Hospital Organisation Nagoya Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Takashi Seto, Medical Doctor
Organizational Affiliation
National Hospital Organization Kyushu Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Fukuoka-shi
Country
Japan
Facility Name
Research Site
City
Kashiwa-shi
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer
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