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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022951-49 | EudraCT Number |
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The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab + BSC | Experimental | Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus BSC until disease progression, withdrawal of consent, death, or intolerance of study drug. |
|
| BSC Alone | Other | Participants received best supportive care until disease progression, withdrawal of consent, or death. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Supportive Care (BSC) | Other | BSC was defined as the best palliative care available as judged appropriate by the investigator and according to institutional guidelines and could include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy as clinically indicated. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date. | From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions or an increase in size of non-target lesions thought be ≥ 20% and an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date. |
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Inclusion Criteria:
Diagnosis of metastatic colorectal cancer (CRC)
Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
At least 1 measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
Treatment failure (defined as failure due to either disease progression [clinical or radiological] or toxicity [treatment intolerance]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination.
Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
Man or woman at least 18 years of age
Adequate hematologic, renal, hepatic and metabolic function
Negative pregnancy test within 72 hours before randomization (for women of childbearing potential only)
Subject or subject's legally acceptable representative has provided informed consent.
Other protocol-specified criteria may apply
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Curitiba | Paraná | 80420-090 | Brazil | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27736842 | Background | Kim TW, Elme A, Kusic Z, Park JO, Udrea AA, Kim SY, Ahn JB, Valencia RV, Krishnan S, Bilic A, Manojlovic N, Dong J, Guan X, Lofton-Day C, Jung AS, Vrdoljak E. A phase 3 trial evaluating panitumumab plus best supportive care vs best supportive care in chemorefractory wild-type KRAS or RAS metastatic colorectal cancer. Br J Cancer. 2016 Nov 8;115(10):1206-1214. doi: 10.1038/bjc.2016.309. Epub 2016 Oct 13. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were stratified according to geographic region (Europe vs Asia vs rest of the world) and Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 vs 2) and randomized (1:1 ratio) to 1 of 2 treatment groups.
A total of 377 participants were randomized at 66 centers in Europe, Asia, North and South America from 8 November 2011 until 30 July 2013.
Results are reported as of the primary analysis data cut-off date of 10 June 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab + BSC | Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug. |
| FG001 | BSC Alone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Panitumumab | Drug | Administered intravenously |
|
|
| From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks). |
| Overall Survival in Participants With Wild-type RAS | A secondary efficacy endpoint was overall survival in participants with wild-type rat sarcoma viral oncogene homolog (RAS) (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS and neuroblastoma RAS viral oncogene (NRAS)). In participants with wild-type RAS, RAS mutation status was defined by KRAS exon 2 mutation status per clinical trial assay testing and mutation status of KRAS exon 3 and 4 and NRAS exons 2, 3 and 4 per Sanger bi-directional sequencing. Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date. | From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks). |
| Progression Free Survival (PFS) in Participants With Wild-type RAS | PFS was defined as the time from the randomization date to the date of disease progression per RECIST version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions, or an increase in size of non-target lesions thought be ≥ 20% with an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date. | From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks). |
| Objective Response Rate | Objective response rate (ORR) is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator's assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions. | Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks). |
| Objective Response Rate in Participants With Wild-type RAS | Objective response rate is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator's assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions. | Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks). |
| Number of Participants With Adverse Events (AEs) | The severity of each AE was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Grade 1 = Mild; 2 = Moderate (discomfort enough to cause interference with usual activity); 3 = Severe (incapacitating with inability to work or do usual activity); 4 = Life-threatening and 5 = Fatal), with the exception of the skin-or nail-related AEs which were graded using a CTCAE version 3.0 with modifications. A serious AE was defined as an AE that met at least 1 of the following criteria: • fatal, • life-threatening, • required in-patient hospitalization or prolongation of existing hospitalization, • resulted in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event. Treatment-related AEs (TRAEs) are those the investigator considered there was reasonable possibility that the event might have been caused by study drug. | From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively. |
| Maximum Post-baseline Change From Baseline in Corrected QT (QTc) Interval | QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle as measured by electrocardiogram (ECG). QTc is the QT interval corrected for heart rate. To evaluate the effect of panitumumab treatment on the QTc interval length among participants treated with panitumumab, ECGs were collected at the following time points from participants randomized to panitumumab arm at a limited number of sites: Week 1 prior to the first panitumumab infusion (Baseline) and within 30 minutes following the end of the first infusion of panitumumab (Cmax), Week 7 after 3 doses of panitumumab (steady state), and at the safety follow-up visit. The ECGs were submitted for independent central review to calculate the reported QTc interval. QTc was calculated using both the Bazett correction (QTcB) and the Fridericia correction (QTcF). | Baseline (pre-dose), Week 1 and Week 7 (post-dose) and 4 weeks after the last dose (Safety Follow-up visit) |
| Natal |
| Rio Grande do Norte |
| 59075-740 |
| Brazil |
| Research Site | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Research Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Research Site | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Research Site | Montreal | Quebec | H1T 2M4 | Canada |
| Research Site | Montreal | Quebec | H4J 1C5 | Canada |
| Research Site | Québec | Quebec | G1R 2J6 | Canada |
| Research Site | Québec | Quebec | G1S 4L8 | Canada |
| Research Site | Trois-Rivières | Quebec | G8Z 3R9 | Canada |
| Research Site | Temuco | Cautín | 4810469 | Chile |
| Research Site | Viña del Mar | Valparaiso | 2520612 | Chile |
| Research Site | Fuzhou | Fujian | 350001 | China |
| Research Site | Fuzhou | Fujian | 350025 | China |
| Research Site | Shijiazhuang | Hebei | 050011 | China |
| Research Site | Nanjing | Jiangsu | 210029 | China |
| Research Site | Changchun | Jilin | 130021 | China |
| Research Site | Shenyang | Liaoning | 110001 | China |
| Research Site | Xi'an | Shaanxi | 710032 | China |
| Research Site | Xi'an | Shaanxi | 710061 | China |
| Research Site | Beijing | 100032 | China |
| Research Site | Chongqing | 400037 | China |
| Research Site | Chongqing | 400042 | China |
| Research Site | Shanghai | 200233 | China |
| Research Site | Osijek | 31000 | Croatia |
| Research Site | Pula | 52100 | Croatia |
| Research Site | Rijeka | 51000 | Croatia |
| Research Site | Split | 21000 | Croatia |
| Research Site | Zagreb | 10000 | Croatia |
| Research Site | Tallinn | 13419 | Estonia |
| Research Site | Tartu | 51014 | Estonia |
| Research Site | Athens | 11522 | Greece |
| Research Site | Chania | 73300 | Greece |
| Research Site | Hyderabad | Andhra Pradesh | 500 024 | India |
| Research Site | Visakhapatnam | Andhra Pradesh | 530 002 | India |
| Research Site | Bangalore | Karnataka | 560 054 | India |
| Research Site | Kochi | Kerala | 682 304 | India |
| Research Site | Mumbai | Maharashtra | 400 012 | India |
| Research Site | Nashik | Maharashtra | 422 004 | India |
| Research Site | Nashik | Maharashtra | 422 005 | India |
| Research Site | Pune | Maharashtra | 411 001 | India |
| Research Site | Chennai | Tamil Nadu | 600 018 | India |
| Research Site | Daugavpils | 5417 | Latvia |
| Research Site | Riga | 1002 | Latvia |
| Research Site | Riga | 1079 | Latvia |
| Research Site | Kaunas | 50009 | Lithuania |
| Research Site | Vilnius | 08660 | Lithuania |
| Research Site | Kuala Lumpur | Kuala Lumpur | 56000 | Malaysia |
| Research Site | Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
| Research Site | Kampung Baharu Nilai | Negeri Sembilan | 71800 | Malaysia |
| Research Site | George Town | Pulau Pinang | 10400 | Malaysia |
| Research Site | Mexico City | Mexico City | 06760 | Mexico |
| Research Site | Mexico City | Mexico City | 14080 | Mexico |
| Research Site | Cuernavaca | Morelos | 62290 | Mexico |
| Research Site | Oaxaca City | Oaxaca | 68000 | Mexico |
| Research Site | Davao City | Davao Region | 8000 | Philippines |
| Research Site | Cebu City | 6000 | Philippines |
| Research Site | Manila | 1000 | Philippines |
| Research Site | Manila | 1008 | Philippines |
| Research Site | Pasay | 1300 | Philippines |
| Research Site | Bucharest | 022328 | Romania |
| Research Site | Bucharest | 022338 | Romania |
| Research Site | Cluj-Napoca | 400006 | Romania |
| Research Site | Cluj-Napoca | 400015 | Romania |
| Research Site | Cluj-Napoca | 400058 | Romania |
| Research Site | Craiova | 200385 | Romania |
| Research Site | Craiova | 200642 | Romania |
| Research Site | Lasi | 700106 | Romania |
| Research Site | Ploieşti | 100337 | Romania |
| Research Site | Suceava | 720237 | Romania |
| Research Site | Timișoara | 300167 | Romania |
| Research Site | Belgrade | 11000 | Serbia |
| Research Site | Kamenitz | 21204 | Serbia |
| Research Site | Niš | 18000 | Serbia |
| Research Site | Goyang-si, Gyeonggi-do | 410-769 | South Korea |
| Research Site | Seoul | 120-752 | South Korea |
| Research Site | Seoul | 135-710 | South Korea |
| Research Site | Seoul | 138-736 | South Korea |
Participants received best supportive care until disease progression, withdrawal of consent, or death. |
| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab + BSC | Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug. |
| BG001 | BSC Alone | Participants received best supportive care until disease progression, withdrawal of consent, or death. |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Geographic Region | Number | participants |
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| Eastern Cooperative Oncology Group (ECOG) Performance Status | A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self care, unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead. | Number | participants |
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| Location of Primary Tumor | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival | Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date. | Intent to Treat (ITT) Analysis Set (all randomized participants); participants in the ITT Analysis Set were required to have wild-type KRAS exon 2 (codons 12 and 13, alleles G12A, G12D, G12R, G12C, G12S, G12V, or G13D) per protocol. | Posted | Median | 95% Confidence Interval | months | From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks). |
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| Secondary | Progression-free Survival | Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions or an increase in size of non-target lesions thought be ≥ 20% and an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | months | From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks). |
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| Secondary | Overall Survival in Participants With Wild-type RAS | A secondary efficacy endpoint was overall survival in participants with wild-type rat sarcoma viral oncogene homolog (RAS) (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS and neuroblastoma RAS viral oncogene (NRAS)). In participants with wild-type RAS, RAS mutation status was defined by KRAS exon 2 mutation status per clinical trial assay testing and mutation status of KRAS exon 3 and 4 and NRAS exons 2, 3 and 4 per Sanger bi-directional sequencing. Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date. | Wild-type RAS Efficacy Analysis Set (subset of participants in the ITT Analysis Set without mutation in exon 2, 3, and 4 of KRAS or NRAS) | Posted | Median | 95% Confidence Interval | months | From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks). |
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| Secondary | Progression Free Survival (PFS) in Participants With Wild-type RAS | PFS was defined as the time from the randomization date to the date of disease progression per RECIST version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions, or an increase in size of non-target lesions thought be ≥ 20% with an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date. | Wild-type RAS Efficacy Analysis Set | Posted | Median | 95% Confidence Interval | months | From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks). |
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| Secondary | Objective Response Rate | Objective response rate (ORR) is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator's assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions. | ITT analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks). |
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| Secondary | Objective Response Rate in Participants With Wild-type RAS | Objective response rate is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator's assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions. | Wild-type RAS Efficacy Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks). |
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| Secondary | Number of Participants With Adverse Events (AEs) | The severity of each AE was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Grade 1 = Mild; 2 = Moderate (discomfort enough to cause interference with usual activity); 3 = Severe (incapacitating with inability to work or do usual activity); 4 = Life-threatening and 5 = Fatal), with the exception of the skin-or nail-related AEs which were graded using a CTCAE version 3.0 with modifications. A serious AE was defined as an AE that met at least 1 of the following criteria: • fatal, • life-threatening, • required in-patient hospitalization or prolongation of existing hospitalization, • resulted in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event. Treatment-related AEs (TRAEs) are those the investigator considered there was reasonable possibility that the event might have been caused by study drug. | Safety Analysis Set (all randomized participants) | Posted | Number | participants | From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively. |
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| Secondary | Maximum Post-baseline Change From Baseline in Corrected QT (QTc) Interval | QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle as measured by electrocardiogram (ECG). QTc is the QT interval corrected for heart rate. To evaluate the effect of panitumumab treatment on the QTc interval length among participants treated with panitumumab, ECGs were collected at the following time points from participants randomized to panitumumab arm at a limited number of sites: Week 1 prior to the first panitumumab infusion (Baseline) and within 30 minutes following the end of the first infusion of panitumumab (Cmax), Week 7 after 3 doses of panitumumab (steady state), and at the safety follow-up visit. The ECGs were submitted for independent central review to calculate the reported QTc interval. QTc was calculated using both the Bazett correction (QTcB) and the Fridericia correction (QTcF). | QTc Analysis Set is defined as the subset of participants in the Safety Analysis Set who received at least one panitumumab dose and were enrolled at the limited number of sites participating in QTc evaluation and had baseline and at least 1 post-baseline QTc assessment. | Posted | Mean | Standard Deviation | msec | Baseline (pre-dose), Week 1 and Week 7 (post-dose) and 4 weeks after the last dose (Safety Follow-up visit) |
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From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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 BSC | 48 | 189 | 174 | 189 | |||
| EG001 | BSC Alone | Participants received best supportive care until disease progression, withdrawal of consent, or death. | 37 | 188 | 74 | 188 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
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| Bone marrow toxicity | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Colorectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Colorectal cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Metastases to ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Wallenberg syndrome | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract inflammation | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 17.0 | 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 |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Asian |
|
| White |
|
| Other |
|
| Asia |
|
| Rest of world |
|
| Grade 1 |
|
| Grade 2 |
|
| Rectum |
|
| Missing |
|
|
|
|
Participants received best supportive care until disease progression, withdrawal of consent, or death. |
|
|
|
|
|
|
|
|
|
|
|
|
Participants received best supportive care until disease progression, withdrawal of consent, or death.
|
|
| OG001 |
| BSC Alone |
Participants received best supportive care until disease progression, withdrawal of consent, or death. |
|
|