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Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)

Primary Purpose

Colon Cancer, Colorectal Cancer, Gastrointestinal Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Panitumumab
Ganitumab
Rilotumumab
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring panitumumab, vectibix, AMG 102, AMG 479, colon cancer, rectal cancer, colorectal cancer, metastatic colorectal cancer, EGFR inhibitor, IGF inhibitor, c-MET inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • metastatic adenocarcinoma of the colon or rectum
  • wild-type KRAS tumor status
  • radiographic evidence of disease progression during or following treatment with irinotecan and/or oxaliplatin containing chemotherapy for mCRC
  • measurable disease >/= 20 mm per Response Evaluation Criteria In Solid Tumors (RECIST)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • adequate laboratory values

Exclusion Criteria:

  • history of central nervous system (CNS) metastases
  • history of another primary cancer, unless:
  • curatively resected non-melanomatous skin cancer
  • curatively treated cervical carcinoma in situ
  • other primary solid tumor treated with curative intent and no known active disease present for >/= 5 years
  • prior treatment with an anti-epithelial growth factor receptor (EGFR), hepatocyte growth factor receptor (HGFR, c-MET), and/or insulin-like growth factor receptor (IGFR) inhibitor
  • prior treatment with AMG 102 or AMG 479
  • prior treatment with chemotherapy or radiotherapy </= 21 days
  • prior treatment with targeted therapy </= 30 days
  • known allergy or hypersensitivity to panitumumab, AMG 102, or AMG 479
  • history of interstitial lung disease
  • clinically significant cardiovascular disease </= 1 year
  • active inflammatory bowel disease
  • known human immunodeficiency virus (HIV), hepatitis C, or hepatitis B infection
  • any co-morbid disease or condition that could increase the risk of toxicity
  • serious or non-healing wound </= 35 days
  • any uncontrolled concurrent illness or history of any medical condition that could interfere with the interpretation of the study results
  • major surgical procedure </= 35 days or minor surgical procedure </= 14 days
  • other investigational procedures or drugs </= 30 days

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Part 1: Panitumumab + Rilotumumab

    Part 2: Panitumumab Alone

    Part 2: Panitumumab + Rilotumumab

    Part 2: Panitumumab + Ganitumab

    Arm Description

    Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.

    Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.

    Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.

    Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.

    Outcomes

    Primary Outcome Measures

    Part 1: Number of Participants With Dose-limiting Toxicities (DLT)
    A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator
    Part 2: Percentage of Participants With an Objective Response
    An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.

    Secondary Outcome Measures

    Part 2: Duration of Response
    The interval from the first visit of a confirmed objective response to disease progression as defined by the modified RECIST v1.0 criteria. Participants who did not progress by the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and the start of Part 3 dosing where applicable were censored at their last evaluable disease assessment date prior to the end of reporting period. Progressive disease is defined as at least a 20% increase in the size of target lesions, or unequivocal progression of existing non-target lesions, or any new lesions.
    Part 2: Time to Response
    The interval from the first dose of study therapy to the date of the first confirmed objective response, calculated only for participants with an objective response.
    Part 2: Percentage of Participants With Disease Control
    The percentage of participants with an overall objective response of CR, PR, or stable disease (SD). CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD). SD: Neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD and no progression of non-target lesions, or the persistence of one or more non-target lesion(s) not qualifying for either CR or PD.
    Progression-free Survival
    The interval from the first dose of study therapy to the earlier date of disease progression (per modified-RECIST v1.0) or death. Participants who did not progress or die by the analysis data cutoff date were censored at their last evaluable disease assessment date prior to the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and receiving study treatment in Part 3 where applicable. Participants enrolled into Part 3 or who started a new line of anti-tumor therapy before radiographic progression but subsequently died were considered as having an event with the event date same as the death date.
    On-treatment Progression-free Survival
    An event is defined as a radiographic progression or death that occurred from the first dose to 28 days since the last dose of study therapy. Participants who did not progress or die during this period were censored at their last evaluable disease assessment before the end of the 28-day period. Participants who received Part 3 treatment before 28 days since their last dose of study drug in Part 2 and did not have radiographic progression or die were censored at their last evaluable disease assessment prior to receiving therapy in Part 3. Radiographic progressions after start of a new anti-tumor therapy, including Part 3 treatment, or after 28 days since the last dose in Part 2 were excluded from the analysis. Participants who died with no prior radiographic disease progression during Part 3 treatment, but within the 28-day period since the last dose in Part 2 were considered as having an event.
    Overall Survival
    The interval from the first dose of study therapy to the date of death. Participants still alive at the analysis data cutoff date were censored at their last contact date.
    Number of Participants With Adverse Events (AEs)
    A serious adverse event (SAE) is defined as an AE that is fatal, life threatening (places the participant at immediate risk of death), requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other significant medical hazard. AEs were graded for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. AEs were assessed by the investigator for the relationship of the AE to each one or more of the investigational products by the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?"
    Number of Participants With Grade 3 or Higher Laboratory Toxicities
    The severity of laboratory toxicities was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal.
    Number of Participants With Antibody Formation to Panitumumab, Rilotumumab and Ganitumab
    Validated immunoassays were used to detect anti-panitumumab, anti-rilotumumab and anti-ganitumab binding antibodies.
    Part 1: Maximum Observed Drug Concentration (Cmax) and Minimum Drug Concentration (Cmin) for Panitumumab and Rilotumumab
    Part 1: Area Under the Drug Concentration-time Curve During a Dosing Interval (AUCtau) for Panitumumab and Rilotumumab
    Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Panitumumab
    Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Panitumumab
    Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).
    Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Rilotumumab
    Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Rilotumumab
    Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).
    Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Ganitumab
    Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Ganitumab
    Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).

    Full Information

    First Posted
    October 23, 2008
    Last Updated
    June 23, 2015
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00788957
    Brief Title
    Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)
    Official Title
    A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination With Panitumumab Versus Panitumumab Alone in Subject With Wild-Type KRAS Metastatic Colorectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    February 2012 (Actual)
    Study Completion Date
    October 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2 part, phase 2 study designed to evaluate the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus panitumumab alone in patients with metastatic colorectal cancer whose tumors are wild-type KRAS status.
    Detailed Description
    This study consisted of 3 parts: Part 1: determination of the tolerable dose of rilotumumab in combination with panitumumab to be administered in Part 2. Part 2: Comparison of the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus that of panitumumab alone. In Part 2, participants were randomized 1:1:1 into 3 cohorts: 6 mg/kg panitumumab plus 10 mg/kg rilotumumab, 6 mg/kg panitumumab plus 12 mg/kg ganitumab, or 6 mg/kg panitumumab and placebo (panitumumab alone cohort). Panitumumab was administered open-label, and rilotumumab and ganitumab were double-blinded. Part 3: Exploratory evaluation of the safety and efficacy of the rilotumumab and ganitumab monotherapy following treatment with panitumumab in Part 2. In Part 3, eligible participants who terminated panitumumab treatment in the Panitumumab Alone arm of Part 2 due to disease progression or intolerability could be randomized 1:1 into 2 double-blind cohorts: 10 mg/kg rilotumumab or 12 mg/kg ganitumab. Participants who permanently discontinued all the investigational products completed a safety follow-up visit 30 days and a follow-up visit 60 days after the last dose of investigational product. Participants were followed for radiographic disease progression and survival every 3 months after the 30-day safety follow-up visit for up to 2 years after the last participant was enrolled in Part 2.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colon Cancer, Colorectal Cancer, Gastrointestinal Cancer, Metastatic Colorectal Cancer, Rectal Cancer
    Keywords
    panitumumab, vectibix, AMG 102, AMG 479, colon cancer, rectal cancer, colorectal cancer, metastatic colorectal cancer, EGFR inhibitor, IGF inhibitor, c-MET inhibitor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    153 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Part 1: Panitumumab + Rilotumumab
    Arm Type
    Experimental
    Arm Description
    Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
    Arm Title
    Part 2: Panitumumab Alone
    Arm Type
    Active Comparator
    Arm Description
    Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
    Arm Title
    Part 2: Panitumumab + Rilotumumab
    Arm Type
    Experimental
    Arm Description
    Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
    Arm Title
    Part 2: Panitumumab + Ganitumab
    Arm Type
    Experimental
    Arm Description
    Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
    Intervention Type
    Drug
    Intervention Name(s)
    Panitumumab
    Other Intervention Name(s)
    Vectibix®
    Intervention Description
    Panitumumab for intravenous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Ganitumab
    Other Intervention Name(s)
    AMG 479
    Intervention Description
    Ganitumab for intravenous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Rilotumumab
    Other Intervention Name(s)
    AMG 102
    Intervention Description
    Rilotumumab for intravenous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo intravenous infusion
    Primary Outcome Measure Information:
    Title
    Part 1: Number of Participants With Dose-limiting Toxicities (DLT)
    Description
    A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator
    Time Frame
    7 weeks
    Title
    Part 2: Percentage of Participants With an Objective Response
    Description
    An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.
    Time Frame
    From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
    Secondary Outcome Measure Information:
    Title
    Part 2: Duration of Response
    Description
    The interval from the first visit of a confirmed objective response to disease progression as defined by the modified RECIST v1.0 criteria. Participants who did not progress by the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and the start of Part 3 dosing where applicable were censored at their last evaluable disease assessment date prior to the end of reporting period. Progressive disease is defined as at least a 20% increase in the size of target lesions, or unequivocal progression of existing non-target lesions, or any new lesions.
    Time Frame
    From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
    Title
    Part 2: Time to Response
    Description
    The interval from the first dose of study therapy to the date of the first confirmed objective response, calculated only for participants with an objective response.
    Time Frame
    From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
    Title
    Part 2: Percentage of Participants With Disease Control
    Description
    The percentage of participants with an overall objective response of CR, PR, or stable disease (SD). CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD). SD: Neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD and no progression of non-target lesions, or the persistence of one or more non-target lesion(s) not qualifying for either CR or PD.
    Time Frame
    From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
    Title
    Progression-free Survival
    Description
    The interval from the first dose of study therapy to the earlier date of disease progression (per modified-RECIST v1.0) or death. Participants who did not progress or die by the analysis data cutoff date were censored at their last evaluable disease assessment date prior to the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and receiving study treatment in Part 3 where applicable. Participants enrolled into Part 3 or who started a new line of anti-tumor therapy before radiographic progression but subsequently died were considered as having an event with the event date same as the death date.
    Time Frame
    From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
    Title
    On-treatment Progression-free Survival
    Description
    An event is defined as a radiographic progression or death that occurred from the first dose to 28 days since the last dose of study therapy. Participants who did not progress or die during this period were censored at their last evaluable disease assessment before the end of the 28-day period. Participants who received Part 3 treatment before 28 days since their last dose of study drug in Part 2 and did not have radiographic progression or die were censored at their last evaluable disease assessment prior to receiving therapy in Part 3. Radiographic progressions after start of a new anti-tumor therapy, including Part 3 treatment, or after 28 days since the last dose in Part 2 were excluded from the analysis. Participants who died with no prior radiographic disease progression during Part 3 treatment, but within the 28-day period since the last dose in Part 2 were considered as having an event.
    Time Frame
    From the date of first dose until 28 days after the last dose until the data cut-off date of 23 July 2010. Median time on treatment was 3.7, 4.9 and 5.1 months in each treatment arm respectively.
    Title
    Overall Survival
    Description
    The interval from the first dose of study therapy to the date of death. Participants still alive at the analysis data cutoff date were censored at their last contact date.
    Time Frame
    From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
    Title
    Number of Participants With Adverse Events (AEs)
    Description
    A serious adverse event (SAE) is defined as an AE that is fatal, life threatening (places the participant at immediate risk of death), requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other significant medical hazard. AEs were graded for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. AEs were assessed by the investigator for the relationship of the AE to each one or more of the investigational products by the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?"
    Time Frame
    From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.
    Title
    Number of Participants With Grade 3 or Higher Laboratory Toxicities
    Description
    The severity of laboratory toxicities was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal.
    Time Frame
    From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.
    Title
    Number of Participants With Antibody Formation to Panitumumab, Rilotumumab and Ganitumab
    Description
    Validated immunoassays were used to detect anti-panitumumab, anti-rilotumumab and anti-ganitumab binding antibodies.
    Time Frame
    From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.
    Title
    Part 1: Maximum Observed Drug Concentration (Cmax) and Minimum Drug Concentration (Cmin) for Panitumumab and Rilotumumab
    Time Frame
    Week 5 (third dose) at pre-dose, 5 minutes after infusion and at 24, 48 and 96, and 168 hours post infusion.
    Title
    Part 1: Area Under the Drug Concentration-time Curve During a Dosing Interval (AUCtau) for Panitumumab and Rilotumumab
    Time Frame
    Week 5 (third dose) at pre-dose, 5 minutes after infusion and at 24, 48 and 96, and 168 hours post infusion.
    Title
    Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Panitumumab
    Time Frame
    Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.
    Title
    Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Panitumumab
    Description
    Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).
    Time Frame
    Pre-dose at Weeks 3, 5, 7, 13 and 23.
    Title
    Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Rilotumumab
    Time Frame
    Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.
    Title
    Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Rilotumumab
    Description
    Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).
    Time Frame
    Pre-dose at Weeks 3, 5, 7, 13 and 23.
    Title
    Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Ganitumab
    Time Frame
    Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.
    Title
    Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Ganitumab
    Description
    Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).
    Time Frame
    Pre-dose at Weeks 3, 5, 7, 13 and 23.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: metastatic adenocarcinoma of the colon or rectum wild-type KRAS tumor status radiographic evidence of disease progression during or following treatment with irinotecan and/or oxaliplatin containing chemotherapy for mCRC measurable disease >/= 20 mm per Response Evaluation Criteria In Solid Tumors (RECIST) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 adequate laboratory values Exclusion Criteria: history of central nervous system (CNS) metastases history of another primary cancer, unless: curatively resected non-melanomatous skin cancer curatively treated cervical carcinoma in situ other primary solid tumor treated with curative intent and no known active disease present for >/= 5 years prior treatment with an anti-epithelial growth factor receptor (EGFR), hepatocyte growth factor receptor (HGFR, c-MET), and/or insulin-like growth factor receptor (IGFR) inhibitor prior treatment with AMG 102 or AMG 479 prior treatment with chemotherapy or radiotherapy </= 21 days prior treatment with targeted therapy </= 30 days known allergy or hypersensitivity to panitumumab, AMG 102, or AMG 479 history of interstitial lung disease clinically significant cardiovascular disease </= 1 year active inflammatory bowel disease known human immunodeficiency virus (HIV), hepatitis C, or hepatitis B infection any co-morbid disease or condition that could increase the risk of toxicity serious or non-healing wound </= 35 days any uncontrolled concurrent illness or history of any medical condition that could interfere with the interpretation of the study results major surgical procedure </= 35 days or minor surgical procedure </= 14 days other investigational procedures or drugs </= 30 days
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24919569
    Citation
    Van Cutsem E, Eng C, Nowara E, Swieboda-Sadlej A, Tebbutt NC, Mitchell E, Davidenko I, Stephenson J, Elez E, Prenen H, Deng H, Tang R, McCaffery I, Oliner KS, Chen L, Gansert J, Loh E, Smethurst D, Tabernero J. Randomized phase Ib/II trial of rilotumumab or ganitumab with panitumumab versus panitumumab alone in patients with wild-type KRAS metastatic colorectal cancer. Clin Cancer Res. 2014 Aug 15;20(16):4240-50. doi: 10.1158/1078-0432.CCR-13-2752. Epub 2014 Jun 11.
    Results Reference
    background
    PubMed Identifier
    26049686
    Citation
    Peeters M, Kafatos G, Taylor A, Gastanaga VM, Oliner KS, Hechmati G, Terwey JH, van Krieken JH. Prevalence of RAS mutations and individual variation patterns among patients with metastatic colorectal cancer: A pooled analysis of randomised controlled trials. Eur J Cancer. 2015 Sep;51(13):1704-13. doi: 10.1016/j.ejca.2015.05.017. Epub 2015 Jun 3.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)

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