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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selumetinib (AZD6244) 25 mg | Experimental | monotherapy |
|
| Selumetinib (AZD6244) 50 mg | Experimental | monotherapy |
|
| Selumetinib (AZD6244) 75 mg | Experimental | monotherapy |
|
| Selumetinib (AZD6244) 75 mg + Doce | Experimental | Combination |
|
| Selumetinib (AZD6244) 25 mg + Doce | Experimental | combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6244 | Drug | Tablet Oral bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Japan | ||||
| Research Site |
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).
First patient enrolled on 01 June 2012. Last subject last visit on 30 March 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Combination Therapy Cohort 2 Selumetinib 25 mg + Doce |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 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 |
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib |
| 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 | 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 | Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose |
| Kashiwa-shi |
| Japan |
| Research Site | Nagoya | Japan |
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 |
| FG002 | Monotherapy Cohort 1 Selumetinib 25 mg | Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies |
| FG003 | Monotherapy Cohort 2 Selumetinib 50 mg | Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies |
| FG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All subjects who received selumetinib were included into the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Monotherapy Cohort 1 Selumetinib 25 mg | Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies |
| BG003 | Monotherapy Cohort 2 Selumetinib 50 mg | Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies |
| BG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax of Selumetinib After Single Dose | Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Tmax of Selumetinib After Single Dose | Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib | Pharmacokinetic Analysis Set | Posted | Median | Full Range | hour | Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Primary | 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 | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Cmax of N-desmethyl Selumetinib After Single Dose | Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Primary | 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 | Pharmacokinetic Analysis Set | Posted | Median | Full Range | hour | Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Primary | 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 | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Primary | 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 | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Primary | 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 | Pharmacokinetic Analysis Set | Posted | Median | Full Range | hour | Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Primary | 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 | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Primary | 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 | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Primary | 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 | Pharmacokinetic Analysis Set | Posted | Median | Full Range | hour | Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Primary | 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 | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Pharmacokinetic Analysis Set | Posted | Median | Full Range | hour | Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Pharmacokinetic Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose |
|
|
Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 4 | 4 | 4 | ||
| EG001 | 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 | 0 | 4 | 4 | 4 | ||
| EG002 | Monotherapy Cohort 1 Selumetinib 25 mg | Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies | 1 | 4 | 4 | 4 | ||
| EG003 | Monotherapy Cohort 2 Selumetinib 50 mg | Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies | 1 | 6 | 6 | 6 | ||
| EG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies | 2 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia bacterial | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Eye oedema | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Xanthopsia | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Vascular pain | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Masahiro Nii | Biometrics Department, Science Affairs Division, R&D, Astrazeneca Japan | Masahiro.Nii@astrazeneca.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C517975 | AZD 6244 |
Not provided
Not provided
Not provided
| Male |
|
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
| OG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies |
|
|
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies |
| OG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies |
|
|
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies |
| OG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies |
|
|
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies |
| OG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies |
|
|
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies |
| OG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies |
|
|
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies |
| OG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies |
|
|
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies |
| OG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies |
|
|
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies |
| OG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies |
|
|
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies |
| OG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies |
|
|
Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies |
| OG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 50 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 |
| OG004 | Monotherapy Cohort 3 Selumetinib 75 mg | Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies |
|
|
|
|
|