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This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Panitumumab + Docetaxel + Cisplatin |
|
| Arm 2 | Other | control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | chemotherapy arm |
| |
| Panitumumab |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) During the First-line Treatment Phase | The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase. | Every 6 weeks until disease progression or death, up to 67 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) During the First-line Treatment Phase | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population. |
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Inclusion Criteria:
Exclusion Criteria:
Prior systemic treatment for metastatic and/or recurrent SCCHN
CNS metastases, or nasopharyngeal carcinoma
History of interstitial lung disease
History of another primary cancer
Any co-morbid disease that would increase risk of toxicity
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85715 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Wirth LJ. PARTNER: a study of panitumumab plus chemotherapy for first-line treatment of advanced head and neck cancer. Commun Oncol. 2008;5(Supp 14):1-4. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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The planned number of subjects to enroll was 110. The actual number of subjects enrolled was 113.
Subjects were enrolled from 29 January 2007 to 1 September 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab Plus Chemotherapy | Panitumumab + Docetaxel + Cisplatin, experiment |
| FG001 | Chemotherapy Alone | Docetaxel + Cisplatin, control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First-line Treatment Phase |
|
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| Drug |
experimental arm |
|
| Docetaxel | Drug | chemotherapy arm |
|
| Cisplatin | Drug | experimental arm |
|
| Docetaxel | Drug | experimental arm |
|
| Every 6 weeks until disease progression or death, up to 67 months |
| Rate of Disease Control (RDC) During the First-line Treatment Phase | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population. | Every 6 weeks until disease progression or death, up to 67 months |
| Duration of Response (DOR) During the First-line Treatment Phase | Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date. | Every 6 weeks until disease progression or death, up to 67 months |
| Time to Response (TTR) During the First-line Treatment Phase | Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter) | Every 6 weeks until disease progression or death, up to 67 months |
| Overall Survival (OS) for the First-line Treatment | Time from the date of randomization to the date of death during the entire study | Until death, up to 67 months |
| Progression Free Survival (PFS) During the Second-line Treatment Phase | The time from the first dose of panitumumab monotherapy to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or the second-line first dose date (whichever is later) during the second-line treatment phase. | Every 6 weeks until disease progression or death, up to 57 months |
| Overall Response Rate (ORR) During the Second-line Treatment Phase | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population. | Every 6 weeks until disease progression or death, up to 57 months |
| Rate of Disease Control (RDC) During the Second-line Treatment Phase | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population. | Every 6 weeks until disease progression or death, up to 57 months |
| Duration of Response (DOR) During the Second-line Treatment Phase | Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date. | Every 6 weeks until disease progression or death, up to 57 months |
| Time to Response (TTR) During the Second-line Treatment Phase | Time from the first dose of panitumumab monotherapy to the first CR or PR during second-line treatment phase (subsequently confirmed at least 4 weeks thereafter) | Every 6 weeks until disease progression or death, up to 57 months |
| Overall Survival (OS) for the Second-line Treatment | Time from the first dose of panitumumab monotherapy to the date of death during the entire study | Until death, up to 57 months |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Research Site | Duarte | California | 91010 | United States |
| Research Site | La Jolla | California | 92037 | United States |
| Research Site | La Verne | California | 91750 | United States |
| Research Site | Los Angeles | California | 90095 | United States |
| Research Site | Santa Cruz | California | 95065 | United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Denver | Colorado | 80210 | United States |
| Research Site | Norwich | Connecticut | 06360 | United States |
| Research Site | Newark | Delaware | 19713 | United States |
| Research Site | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Washington D.C. | District of Columbia | 20010 | United States |
| Research Site | Washington D.C. | District of Columbia | 20037 | United States |
| Research Site | Washington D.C. | District of Columbia | 20422 | United States |
| Research Site | Lakeland | Florida | 33805 | United States |
| Research Site | Miami | Florida | 33176 | United States |
| Research Site | New Port Richey | Florida | 34655 | United States |
| Research Site | Orlando | Florida | 32806 | United States |
| Research Site | Athens | Georgia | 30607 | United States |
| Research Site | Griffin | Georgia | 30224 | United States |
| Research Site | Marietta | Georgia | 30060 | United States |
| Research Site | Centralia | Illinois | 62801 | United States |
| Research Site | Elk Grove Village | Illinois | 60007 | United States |
| Research Site | Evanston | Illinois | 60201 | United States |
| Research Site | Park Ridge | Illinois | 60068 | United States |
| Research Site | Zion | Illinois | 60099 | United States |
| Research Site | Wichita | Kansas | 67214 | United States |
| Research Site | Ashland | Kentucky | 41101 | United States |
| Research Site | Lexington | Kentucky | 40536 | United States |
| Research Site | Louisville | Kentucky | 40202-1703 | United States |
| Research Site | Louisville | Kentucky | 40202 | United States |
| Research Site | Paducah | Kentucky | 42003 | United States |
| Research Site | Baltimore | Maryland | 21204 | United States |
| Research Site | Baltimore | Maryland | 21237 | United States |
| Research Site | Frederick | Maryland | 21701 | United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | Ann Arbor | Michigan | 48106-0995 | United States |
| Research Site | Lansing | Michigan | 48910 | United States |
| Research Site | Pascagoula | Mississippi | 39581 | United States |
| Research Site | Columbia | Missouri | 65201 | United States |
| Research Site | Jefferson City | Missouri | 65109 | United States |
| Research Site | St Louis | Missouri | 63110-1093 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Billings | Montana | 59102 | United States |
| Research Site | Omaha | Nebraska | 68114 | United States |
| Research Site | Henderson | Nevada | 59074 | United States |
| Research Site | Hackensack | New Jersey | 07601 | United States |
| Research Site | Binghamton | New York | 13905 | United States |
| Research Site | Mineola | New York | 11501 | United States |
| Research Site | New York | New York | 10003 | United States |
| Research Site | New York | New York | 10032 | United States |
| Research Site | Nyack | New York | 10960 | United States |
| Research Site | Rochester | New York | 14623 | United States |
| Research Site | Syracuse | New York | 13210 | United States |
| Research Site | The Bronx | New York | 10457 | United States |
| Research Site | The Bronx | New York | 10467 | United States |
| Research Site | Canton | Ohio | 44718 | United States |
| Research Site | Cincinnati | Ohio | 45236 | United States |
| Research Site | Dayton | Ohio | 45420 | United States |
| Research Site | Toledo | Ohio | 43614 | United States |
| Research Site | Oklahoma City | Oklahoma | 73104 | United States |
| Research Site | Langhorne | Pennsylvania | 19047 | United States |
| Research Site | Philadelphia | Pennsylvania | 19107 | United States |
| Research Site | Scranton | Pennsylvania | 18510 | United States |
| Research Site | Charleston | South Carolina | 29406 | United States |
| Research Site | Charleston | South Carolina | 29425 | United States |
| Research Site | Greenville | South Carolina | 29615 | United States |
| Research Site | Memphis | Tennessee | 38120 | United States |
| Research Site | Arlington | Texas | 76012 | United States |
| Research Site | Corpus Christi | Texas | 78405 | United States |
| Research Site | Corpus Christi | Texas | 78412 | United States |
| Research Site | Dallas | Texas | 75201 | United States |
| Research Site | Dallas | Texas | 75230 | United States |
| Research Site | Dallas | Texas | 75234 | United States |
| Research Site | Galveston | Texas | 77555-0158 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Abingdon | Virginia | 24211 | United States |
| Research Site | Chesapeake | Virginia | 23320 | United States |
| Research Site | Morgantown | West Virginia | 26506 | United States |
| Research Site | Madison | Wisconsin | 53792 | United States |
| Research Site | Marshfield | Wisconsin | 54449 | United States |
| Research Site | Graz | 8036 | Austria |
| Research Site | Leoben | 8700 | Austria |
| Research Site | Linz | 4010 | Austria |
| Research Site | Vienna | 1090 | Austria |
| Research Site | Brasschaat | 2930 | Belgium |
| Research Site | Bruges | 8000 | Belgium |
| Research Site | Kortrijk | 8500 | Belgium |
| Research Site | Libramont | 6800 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Ottignies | 1340 | Belgium |
| Research Site | Wilrijk | 2610 | Belgium |
| Research Site | Brno | 656 53 | Czechia |
| Research Site | Prague | 150 06 | Czechia |
| Research Site | Znojmo | 669 02 | Czechia |
| Research Site | Angers | 49933 | France |
| Research Site | Lens | 62307 | France |
| Research Site | Perpignan | 66000 | France |
| Research Site | Vandœuvre-lès-Nancy | 54511 | France |
| Research Site | Kaunas | 45434 | Lithuania |
| Research Site | Vilnius | 08660 | Lithuania |
| Research Site | San Juan | 00935 | Puerto Rico |
| Research Site | Banská Bystrica | 974 01 | Slovakia |
| Research Site | Bratislava | 812 50 | Slovakia |
| Research Site | Nové Zámky | 940 34 | Slovakia |
| Research Site | Prešov | 080 01 | Slovakia |
| Research Site | Spišská Nová Ves | 052 01 | Slovakia |
| Research Site | Santander | Cantabria | 39008 | Spain |
| Research Site | Barcelona | Catalonia | 08025 | Spain |
| Research Site | Girona | Catalonia | 17007 | Spain |
| Research Site | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Research Site | Valencia | Valencia | 46009 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Received Study Medication |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Second-line Treatment Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab Plus Chemotherapy | Panitumumab + Docetaxel + Cisplatin, experiment |
| BG001 | Chemotherapy Alone | Docetaxel + Cisplatin, control |
| BG002 | 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 | Progression Free Survival (PFS) During the First-line Treatment Phase | The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase. | All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab) | Posted | Median | 95% Confidence Interval | Months | Every 6 weeks until disease progression or death, up to 67 months |
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| Secondary | Overall Response Rate (ORR) During the First-line Treatment Phase | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population. | all randomized subjects < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review | Posted | Mean | 95% Confidence Interval | Percentage of Participants | Every 6 weeks until disease progression or death, up to 67 months |
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| Secondary | Rate of Disease Control (RDC) During the First-line Treatment Phase | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population. | all randomized subjects < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review | Posted | Mean | 95% Confidence Interval | Percentage of Participants | Every 6 weeks until disease progression or death, up to 67 months |
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| Secondary | Duration of Response (DOR) During the First-line Treatment Phase | Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date. | All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review and objective response | Posted | Median | 95% Confidence Interval | Months | Every 6 weeks until disease progression or death, up to 67 months |
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| Secondary | Time to Response (TTR) During the First-line Treatment Phase | Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter) | All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review and objective response | Posted | Mean | Standard Deviation | Weeks | Every 6 weeks until disease progression or death, up to 67 months |
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| Secondary | Overall Survival (OS) for the First-line Treatment | Time from the date of randomization to the date of death during the entire study | All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab) | Posted | Median | 95% Confidence Interval | Months | Until death, up to 67 months |
|
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| Secondary | Progression Free Survival (PFS) During the Second-line Treatment Phase | The time from the first dose of panitumumab monotherapy to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or the second-line first dose date (whichever is later) during the second-line treatment phase. | Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy | Posted | Median | 95% Confidence Interval | Months | Every 6 weeks until disease progression or death, up to 57 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) During the Second-line Treatment Phase | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population. | Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy | Posted | Mean | 95% Confidence Interval | Percentage of Participants | Every 6 weeks until disease progression or death, up to 57 months |
|
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| Secondary | Rate of Disease Control (RDC) During the Second-line Treatment Phase | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population. | Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy | Posted | Mean | 95% Confidence Interval | Percentage of Participants | Every 6 weeks until disease progression or death, up to 57 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) During the Second-line Treatment Phase | Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date. | Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review and objective response | Posted | Median | 95% Confidence Interval | Months | Every 6 weeks until disease progression or death, up to 57 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) During the Second-line Treatment Phase | Time from the first dose of panitumumab monotherapy to the first CR or PR during second-line treatment phase (subsequently confirmed at least 4 weeks thereafter) | Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review and objective response | Posted | Mean | Standard Deviation | Weeks | Every 6 weeks until disease progression or death, up to 57 months |
|
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| Secondary | Overall Survival (OS) for the Second-line Treatment | Time from the first dose of panitumumab monotherapy to the date of death during the entire study | Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy | Posted | Median | 95% Confidence Interval | Months | Until death, up to 57 months |
|
|
The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date of the first-line treatment. The median time frame is 4.5 months for Panitumumab Plus Chemotherapy arm and 4.4 months for Chemotherapy Alone arm.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Panitumumab Plus Chemotherapy | Panitumumab + Docetaxel + Cisplatin, experiment | 34 | 56 | 54 | 56 | ||
| EG001 | Chemotherapy Alone | Docetaxel + Cisplatin, control | 27 | 55 | 53 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Aphagia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oral cavity fistula | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Stenotrophomonas infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Feeding tube complication | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Head and neck cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Tumour ulceration | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arterial haemorrhage | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077544 | Panitumumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Ongoing |
|
| Male |
|
| Log Rank |
Stratified by IVRS randomization factors |
| 0.048 |
| Superiority or Other |
| Participants |
|
|
|
|
|
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|
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|
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