Trial Outcomes & Findings for Conatumumab/Panitumumab Combination Metastatic Colorectal Cancer Study (NCT NCT00630786)

NCT ID: NCT00630786

Last Updated: 2014-02-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 53 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2014-02-06

Participant Flow

Participants were enrolled from 12 January 2008 through 6 November 2008

Participant milestones

Measure	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.	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.	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.
Overall Study STARTED	19	25	9
Overall Study Received Study Medication	19	25	8
Overall Study COMPLETED	18	23	7
Overall Study NOT COMPLETED	1	2	2

Reasons for withdrawal

Measure	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.	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.	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.
Overall Study Physician Decision	0	0	1
Overall Study Withdrawal by Subject	0	1	1
Overall Study Lost to Follow-up	0	1	0
Overall Study Other	1	0	0

Baseline Characteristics

Conatumumab/Panitumumab Combination Metastatic Colorectal Cancer Study

Baseline characteristics by cohort

Measure	Wild-type KRAS n=19 Participants 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.	Mutant KRAS n=25 Participants 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.	Unknown KRAS n=8 Participants 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.	Total n=52 Participants Total of all reporting groups
Age, Continuous	61.53 years STANDARD_DEVIATION 12.53 • n=5 Participants	64.32 years STANDARD_DEVIATION 12.35 • n=7 Participants	58.63 years STANDARD_DEVIATION 13.65 • n=5 Participants	62.42 years STANDARD_DEVIATION 12.54 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	14 Participants n=7 Participants	5 Participants n=5 Participants	25 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized White or Caucasian	16 participants n=5 Participants	24 participants n=7 Participants	7 participants n=5 Participants	47 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	3 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Panitumumab Plus Conatumumab n=5 Participants Participants 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.	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.
Part 1: Number of Participants With Dose-limiting Toxicities	0 participants	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Panitumumab Plus Conatumumab n=18 Participants Participants 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.	Mutant KRAS n=25 Participants 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.
Number of Participants With an Objective Response	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Panitumumab Plus Conatumumab n=19 Participants Participants 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.	Mutant KRAS n=25 Participants 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.
Progression-free Survival	10.0 weeks Interval 7.0 to 23.0	7.1 weeks Interval 6.7 to 8.0

SECONDARY outcome

Timeframe: 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.

Kaplan-Meier estimate of time from enrollment to death from any cause

Outcome measures

Measure	Panitumumab Plus Conatumumab n=19 Participants Participants 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.	Mutant KRAS n=25 Participants 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.
Overall Survival	7.3 months Interval 3.2 to 15.0	4.4 months Interval 3.4 to 8.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Panitumumab Plus Conatumumab n=19 Participants Participants 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.	Mutant KRAS n=25 Participants 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.
Number of Participants With Disease Control	8 participants	4 participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Number of participants with human anti-panitumumab antibodies (HAPA) or anti-conatumumab antibodies measured by immunoassay.

Outcome measures

Measure	Panitumumab Plus Conatumumab n=52 Participants Participants 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.	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.
Number of Participants With Anti-therapeutic Antibodies Anti-panitumumab Antibody at Baseline (N=51)	0 participants	—
Number of Participants With Anti-therapeutic Antibodies Anti-panitumumab Antibody Post-baseline (N=37)	2 participants	—
Number of Participants With Anti-therapeutic Antibodies Anti-conatumumab Antibody at Baseline (N=50)	1 participants	—
Number of Participants With Anti-therapeutic Antibodies Anti-conatumumab Antibody Post-baseline (N=37)	0 participants	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Panitumumab Plus Conatumumab n=52 Participants Participants 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.	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.
Number of Participants With Adverse Events (AEs) Any adverse event	51 participants	—
Number of Participants With Adverse Events (AEs) Grade 3 adverse event	16 participants	—
Number of Participants With Adverse Events (AEs) Grade 4 adverse event	4 participants	—
Number of Participants With Adverse Events (AEs) Grade 5 adverse event	6 participants	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Panitumumab Plus Conatumumab n=52 Participants Participants 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.	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.
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Alanine Amino Transferase increase	4 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Alkaline Phosphatase increase	9 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Amylase increase	2 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Aspartate Amino Transferase increase	5 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Bicarbonate decrease	1 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Calcium increase	1 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Calcium decrease	3 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Glucose increase	1 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Lipase increase	2 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Magnesium decrease	4 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Magnesium increase	1 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Phosphorus decrease	1 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Sodium decrease	1 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Total Bilirubin increase	6 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Absolute Neutrophil Count decrease	7 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Hemoglobin decrease	4 participants	—
Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher Lymphocytes decrease	7 participants	—

Adverse Events

Panitumumab + AMG 655

Serious events: 26 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Measure	Panitumumab + AMG 655 n=52 participants at risk
Cardiac disorders Atrial fibrillation	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal hernia obstructive	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	3.8% 2/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Pneumoperitoneum	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Small intestinal obstruction	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Subileus	3.8% 2/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chills	3.8% 2/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders General physical health deterioration	7.7% 4/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Performance status decreased	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	7.7% 4/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Bile duct obstruction	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Biliary dilatation	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hyperbilirubinaemia	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Jaundice	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abdominal wall abscess	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Clostridial infection	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Folliculitis	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gastroenteritis	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Peritonitis bacterial	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Rash pustular	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sinusitis	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	3.8% 2/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebrovascular accident	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Sciatica	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Pelvic fluid collection	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory distress	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Erythema	1.9% 1/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Measure	Panitumumab + AMG 655 n=52 participants at risk
Blood and lymphatic system disorders Anaemia	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Growth of eyelashes	13.5% 7/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal distension	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	17.3% 9/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain upper	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	11.5% 6/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	17.3% 9/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	30.8% 16/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oral pain	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Stomatitis	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	32.7% 17/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	13.5% 7/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chills	13.5% 7/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	38.5% 20/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Mucosal inflammation	19.2% 10/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema peripheral	9.6% 5/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pain	9.6% 5/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	17.3% 9/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Folliculitis	9.6% 5/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Paronychia	11.5% 6/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Procedural pain	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Weight decreased	9.6% 5/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Anorexia	26.9% 14/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypomagnesaemia	19.2% 10/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Muscle spasms	7.7% 4/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	13.5% 7/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dysgeusia	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Neuralgia	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.5% 7/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Acne	11.5% 6/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Dermatitis acneiform	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Dry skin	19.2% 10/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Erythema	23.1% 12/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Hair growth abnormal	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Pruritus	15.4% 8/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Rash	53.8% 28/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Scab	13.5% 7/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin exfoliation	5.8% 3/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin fissures	15.4% 8/52 • From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. 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.
• Publication restrictions are in place

Restriction type: OTHER