Colon Cancer, Colorectal Cancer, Rectal Cancer, Metastatic Colorectal Cancer, Oncology
Conditions
Brief summary
This is an exploratory phase 1b/2, global, multicenter, single-arm, 2-part (phase 1b and 2) study of conatumumab in combination with panitumumab in patients with Metastatic Colorectal Cancer.
Detailed description
This is an exploratory phase 1b/2, global, multicenter, single-arm, 2-part (phase 1b and 2) study of conatumumab in combination with panitumumab in patients with Metastatic Colorectal Cancer. The objective for Part 1 is to identify a tolerable dose of conatumumab in combination with panitumumab based on the incidence of dose-limiting toxicities in patients with Metastatic Colorectal Cancer. The objective for Part 2 is to evaluate the objective response rate stratified by Kirsten Rat Sarcoma Virus Oncogene (KRAS) status (wild-type versus mutant) in patients with Metastatic Colorectal Cancer treated with the combination of panitumumab and conatumumab (tolerable dose identified in part 1).
Interventions
DRUGPanitumumab
Administered by intravenous infusion
DRUGConatumumab
Administered by intravenous infusion
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum * Radiographically documented disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) during or following treatment with fluoropyrimidine, irinotecan, and/or oxaliplatin chemotherapy for Metastatic Colorectal Cancer. Progressive disease must be documented during or ≤ 6 months after the last dose of the most recent chemotherapy regimen prior to enrollment. * At least 1 uni-dimensionally measurable lesion measuring ≥ 20 mm in one dimension per modified RECIST. Lesion must not be chosen from a previously irradiated field, unless there has been documented disease progression in that field after irradiation and prior to enrollment. All sites of disease must be evaluated. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Available archived paraffin-embedded tumor tissue from the primary tumor or metastasis for submission to the central laboratory * Man or woman ≥ 18 years of age at the time of enrollment * Hematologic function within the following limits: * Absolute neutrophil count (ANC) \> 1.0 x 10\^9 cells/L * Platelets ≥ 100 x 10\^9/L * Renal function within the following limits: * Creatinine \< 2.0 mg/dL * Hepatic function within the following limits: * Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN if liver metastases) * Alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases) * Bilirubin ≤ 2 x ULN * Metabolic function within the following limits: * Amylase ≤ 2 x ULN * Lipase ≤ 2 x ULN * Magnesium ≥ lower limit of normal * Negative pregnancy test ≤ 72 hours before enrollment (for woman of childbearing potential only) * Must have received 1, 2, or 3 prior chemotherapy regimens for Metastatic Colorectal Cancer * Competent to comprehend, sign, and date the independent ethics committee/institutional review board (IEC/IRB) approved written informed consent
Exclusion criteria
* History of other primary cancer, unless: * Curatively resected non-melanomatous skin cancer * Curatively treated cervical carcinoma in situ * Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 5 years before enrollment * Prior treatment with anti-epidermal growth factor receptor (EGFr) inhibitors (eg, cetuximab, erlotinib, gefitinib), unless treatment was received in the adjuvant setting ≥ 6 months before enrollment * Use of systemic chemotherapy and radiotherapy ≤ 30 days before enrollment * Use of prior anti-tumor therapies with a short serum half-life (less than 1 week) including prior experimental agents or approved anti-tumor small molecules ≤ 30 days before enrollment * Use of anti-tumor therapies with a longer serum half-life (eg, bevacizumab) including prior experimental or approved protein/antibodies ≤ 42 days before enrollment * Any investigational agent or therapy ≤ 30 days before enrollment * Known allergy or hypersensitivity to any component of panitumumab and/or AMG 655 * History of or known presence of central nervous system (CNS) metastases * History of interstitial lung disease (eg, pneumonitis, pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan * Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment * Active inflammatory bowel disease or other active bowel disease causing chronic diarrhea (defined as ≥ Common Terminology Criteria for Adverse Events \[CTCAE\] grade 2 \[CTCAE version 3.0\]) * Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection * Any co-morbid disease or condition that could increase the risk of toxicity (eg, significant ascites, significant pleural effusion) * Any uncontrolled concurrent illness (eg, infection, bleeding) or history of any medical condition that may interfere with the interpretation of the study results * Major surgical procedure (requiring general anesthesia) ≤ 28 days or minor surgical procedure (excluding central venous catheter placement) ≤ 14 days before enrollment. Patients must have recovered from surgery related toxicities. * Other investigational procedures are excluded * Patient is currently pregnant or breast feeding * Man or woman of childbearing potential who is not willing to use adequate contraceptive precautions during treatment and for 6 months (for women) or 1 month (for men) after the last investigational product administration. Adequate contraceptive precautions includes double barrier contraceptive methods (eg, diaphragm and condom) or abstinence. * Previously enrolled into this study * Patient unwilling or unable to comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With Dose-limiting Toxicities | 4 weeks | A dose-limiting toxicity (DLT) was defined as any grade 3 or 4 conatumumab-related or combination (panitumumab and conatumumab)-related adverse event, or grade 3 or 4 laboratory abnormality that occurred during the first 4 weeks (28 days) of treatment with panitumumab and conatumumab. Anemia and lymphopenia were not considered DLTs. Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to grade all adverse events and toxicities. |
| Number of Participants With an Objective Response | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). | An overall objective response of either a confirmed complete response or partial response, where the overall objective response was equivalent to the best overall response recorded for each participant from enrollment until disease progression or recurrence. Tumor response was assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Responses were confirmed no less than 4 weeks after the criteria for response were first met. Complete response defined as the disappearance of all target and non-target lesions and no new lesions. Partial response defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Disease Control | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). | Disease control defined as participants with an overall objective response of complete response (CR), partial response (PR), or stable disease during the treatment period, assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST). Responses were confirmed no less than 4 weeks after the criteria for response were first met. CR defined as the disappearance of all target and non-target lesions and no new lesions. PR defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the nadir LD since the treatment started. |
| Time to Response | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). | The interval in days from the first dose of study therapy to the date of first confirmed objective response. Calculated only for participants with an objective response. |
| Duation of Response | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). | The interval in days from the first confirmed objective response to disease progression per the modified RECIST criteria or death. Calculated only for participants with an objective response. |
| Progression-free Survival | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). | Kaplan-Meier estimate of the median time from enrollment to death from any cause or disease progression. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions. |
| Number of Participants With Adverse Events (AEs) | From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, and includes any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition from the time that a participant has signed informed consent to the time of initiation of investigational product. The severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following: 1. = Mild: Aware of sign or symptom, but easily tolerated 2. = Moderate: Discomfort enough to cause interference with usual activity; 3. = Severe: Incapacitating with inability to work or do usual activity; 4. = Life-threatening: an event in which the patient was, in the view of the investigator, at risk of death at the time of the event; 5. = Fatal. |
| Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. | Laboratory values were assessed using the National Cancer Institute (NCI) Common Toxicity Criteria (version 3.0) according to the following: 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Life-threatening; 5 = Fatal. |
| Number of Participants With Anti-therapeutic Antibodies | Antibody samples were collected at weeks 1, 7, and 23 and every 6 months thereafter during treatment, and at the safety follow-up and follow-up visits. The mean follow-up time was 35.7 weeks. | Number of participants with human anti-panitumumab antibodies (HAPA) or anti-conatumumab antibodies measured by immunoassay. |
| Overall Survival | Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). | Kaplan-Meier estimate of time from enrollment to death from any cause |
Participant flow
Recruitment details
Participants were enrolled from 12 January 2008 through 6 November 2008
Participants by arm
| Arm | Count |
|---|---|
| Wild-type KRAS Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death. | 19 |
| Mutant KRAS Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death. | 25 |
| Unknown KRAS Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death. | 8 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Other | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Wild-type KRAS | Mutant KRAS | Unknown KRAS | Total |
|---|---|---|---|---|
| Age, Continuous | 61.53 years STANDARD_DEVIATION 12.53 | 64.32 years STANDARD_DEVIATION 12.35 | 58.63 years STANDARD_DEVIATION 13.65 | 62.42 years STANDARD_DEVIATION 12.54 |
| Race/Ethnicity, Customized Black or African American | 3 participants | 0 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White or Caucasian | 16 participants | 24 participants | 7 participants | 47 participants |
| Sex: Female, Male Female | 13 Participants | 11 Participants | 3 Participants | 27 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 5 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 51 / 52 |
| serious Total, serious adverse events | 26 / 52 |
Outcome results
Primary
Number of Participants With an Objective Response
An overall objective response of either a confirmed complete response or partial response, where the overall objective response was equivalent to the best overall response recorded for each participant from enrollment until disease progression or recurrence. Tumor response was assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Responses were confirmed no less than 4 weeks after the criteria for response were first met. Complete response defined as the disappearance of all target and non-target lesions and no new lesions. Partial response defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions.
Time frame: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).
Population: Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status and Baseline measurable disease.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Panitumumab Plus Conatumumab | Number of Participants With an Objective Response | 0 participants |
| Mutant KRAS | Number of Participants With an Objective Response | 0 participants |
Primary
Part 1: Number of Participants With Dose-limiting Toxicities
A dose-limiting toxicity (DLT) was defined as any grade 3 or 4 conatumumab-related or combination (panitumumab and conatumumab)-related adverse event, or grade 3 or 4 laboratory abnormality that occurred during the first 4 weeks (28 days) of treatment with panitumumab and conatumumab. Anemia and lymphopenia were not considered DLTs. Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to grade all adverse events and toxicities.
Time frame: 4 weeks
Population: DLT-evaluable patients were those who received ≥ 2 doses of panitumumab and conatumumab as scheduled (ie, weeks 1 and 3) and completed 4 weeks (28 days) of treatment, or had a DLT within the first 4 weeks (28 days) of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Panitumumab Plus Conatumumab | Part 1: Number of Participants With Dose-limiting Toxicities | 0 participants |
Secondary
Duation of Response
The interval in days from the first confirmed objective response to disease progression per the modified RECIST criteria or death. Calculated only for participants with an objective response.
Time frame: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).
Population: Patients with an overall objective response
Secondary
Number of Participants With Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, and includes any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition from the time that a participant has signed informed consent to the time of initiation of investigational product. The severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following: 1. = Mild: Aware of sign or symptom, but easily tolerated 2. = Moderate: Discomfort enough to cause interference with usual activity; 3. = Severe: Incapacitating with inability to work or do usual activity; 4. = Life-threatening: an event in which the patient was, in the view of the investigator, at risk of death at the time of the event; 5. = Fatal.
Time frame: From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks.
Population: Safety Analysis Set, including all randomized patients who received at least one dose of investigational drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panitumumab Plus Conatumumab | Number of Participants With Adverse Events (AEs) | Any adverse event | 51 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Adverse Events (AEs) | Grade 3 adverse event | 16 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Adverse Events (AEs) | Grade 4 adverse event | 4 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Adverse Events (AEs) | Grade 5 adverse event | 6 participants |
Secondary
Number of Participants With Anti-therapeutic Antibodies
Number of participants with human anti-panitumumab antibodies (HAPA) or anti-conatumumab antibodies measured by immunoassay.
Time frame: Antibody samples were collected at weeks 1, 7, and 23 and every 6 months thereafter during treatment, and at the safety follow-up and follow-up visits. The mean follow-up time was 35.7 weeks.
Population: Safety analysis set, including all randomized patients who received at least 1 dose of investigational product. N indicates the number of patients with immunoassay results at the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panitumumab Plus Conatumumab | Number of Participants With Anti-therapeutic Antibodies | Anti-panitumumab Antibody at Baseline (N=51) | 0 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Anti-therapeutic Antibodies | Anti-panitumumab Antibody Post-baseline (N=37) | 2 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Anti-therapeutic Antibodies | Anti-conatumumab Antibody at Baseline (N=50) | 1 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Anti-therapeutic Antibodies | Anti-conatumumab Antibody Post-baseline (N=37) | 0 participants |
Secondary
Number of Participants With Disease Control
Disease control defined as participants with an overall objective response of complete response (CR), partial response (PR), or stable disease during the treatment period, assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST). Responses were confirmed no less than 4 weeks after the criteria for response were first met. CR defined as the disappearance of all target and non-target lesions and no new lesions. PR defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the nadir LD since the treatment started.
Time frame: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).
Population: Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug, who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Panitumumab Plus Conatumumab | Number of Participants With Disease Control | 8 participants |
| Mutant KRAS | Number of Participants With Disease Control | 4 participants |
Secondary
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher
Laboratory values were assessed using the National Cancer Institute (NCI) Common Toxicity Criteria (version 3.0) according to the following: 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Life-threatening; 5 = Fatal.
Time frame: From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks.
Population: Safety Analysis Set, including all randomized patients who received at least one dose of investigational drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Alanine Amino Transferase increase | 4 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Alkaline Phosphatase increase | 9 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Amylase increase | 2 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Aspartate Amino Transferase increase | 5 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Bicarbonate decrease | 1 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Calcium increase | 1 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Calcium decrease | 3 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Glucose increase | 1 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Lipase increase | 2 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Magnesium decrease | 4 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Magnesium increase | 1 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Phosphorus decrease | 1 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Sodium decrease | 1 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Total Bilirubin increase | 6 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Absolute Neutrophil Count decrease | 7 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Hemoglobin decrease | 4 participants |
| Panitumumab Plus Conatumumab | Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher | Lymphocytes decrease | 7 participants |
Secondary
Overall Survival
Kaplan-Meier estimate of time from enrollment to death from any cause
Time frame: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).
Population: Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug, who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Panitumumab Plus Conatumumab | Overall Survival | 7.3 months |
| Mutant KRAS | Overall Survival | 4.4 months |
Secondary
Progression-free Survival
Kaplan-Meier estimate of the median time from enrollment to death from any cause or disease progression. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.
Time frame: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).
Population: Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Panitumumab Plus Conatumumab | Progression-free Survival | 10.0 weeks |
| Mutant KRAS | Progression-free Survival | 7.1 weeks |
Secondary
Time to Response
The interval in days from the first dose of study therapy to the date of first confirmed objective response. Calculated only for participants with an objective response.
Time frame: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).
Population: Patients with an overall objective response