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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

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ClinicalTrials.gov Identifier: NCT01605916
Recruitment Status : Completed
First Posted : May 25, 2012
Results First Posted : July 14, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neoplasms, Metastatic Cancer, Non-Small Cell Lung Cancer Advanced Solid Malignancies Drug: AZD6244 Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Selumetinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Selumetinib (AZD6244) 25 mg
monotherapy
 Drug: AZD6244
Tablet Oral bid
Other Name: Selumetinib (AZD6244)
Experimental: Selumetinib (AZD6244) 50 mg
monotherapy
 Drug: AZD6244
Tablet Oral bid
Other Name: Selumetinib (AZD6244)
Experimental: Selumetinib (AZD6244) 75 mg
monotherapy
 Drug: AZD6244
Tablet Oral bid
Other Name: Selumetinib (AZD6244)
Experimental: Selumetinib (AZD6244) 75 mg + Doce
Combination
 Drug: AZD6244
Tablet Oral bid
Other Name: Selumetinib (AZD6244)
Experimental: Selumetinib (AZD6244) 25 mg + Doce
combination
 Drug: AZD6244
Tablet Oral bid
Other Name: Selumetinib (AZD6244)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib

  2. 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 ]
    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib

  3. 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 ]
    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

  4. 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 ]
    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib

  5. 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 ]
    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib

  6. 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 ]
    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

  7. 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 ]
    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib

  8. 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 ]
    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib

  9. 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 ]
    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

  10. 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 ]
    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib

  11. 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 ]
    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib

  12. 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 ]
    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 :
  1. 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 ]
    Pharmacokinetic parameter (Cmax: maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib

  2. 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 ]
    Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib

  3. 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 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605916


Locations
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Japan
Research Site
Fukuoka-shi, Japan
Research Site
Kashiwa-shi, Japan
Research Site
Nagoya-shi, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Ian Smith, Medical Science Director AstraZeneca
Principal Investigator: 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
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01605916    
Other Study ID Numbers: D1532C00067
First Posted: May 25, 2012    Key Record Dates
Results First Posted: July 14, 2016
Last Update Posted: October 21, 2016
Last Verified: September 2016
Keywords provided by AstraZeneca:
Cancer,
Tumour,
Metastatic,
Lung cancer,
Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms