Health Condition 1: C189- Malignant neoplasm of colon, unspecified Health Condition 2: C20- Malignant neoplasm of rectum Health Condition 3: null- Metastatic Colorectal Cancer
Conditions
Interventions
Intervention1: Experimental: Pmab + BSC ( Best Supportive care ): Panitumumab (administered intravenously 6 mg/kg every 14 days) plus BSC ( Best Supportive care )- every 14 days.
Control Intervention1
Sponsors
Amgen Technology Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Diagnosis of metastatic colorectal cancer Wild type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory ECOG performance status of 0, 1 or 2 At least 1 measurable or non measurable lesion per RECIST version 1.1 guidelines. Treatment failure (defined as failure due to either disease progression [clinical or radiological] or toxicity [treatment intolerance]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination. Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil uracil) at any point for treatment of CRC Man or woman at least 18 years of age Adequate hematologic, renal, hepatic and metabolic function Negative pregnancy test within 72 hours before randomization (for women of childbearing potential only) Subject or subjects legally acceptable representative has provided informed consent. Other protocol specified criteria may apply
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Symptomatic brain metastases requiring treatment History of another primary cancer within 5 years of randomization Prior anti-EGFR antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFR inhibitors (eg, gefitinib, erlotinib, lapatinib) Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) within 21 days before randomization Radiotherapy within 14 days before randomization. Exclusion Criteria for QTc Evaluation Subpart of the Study: Prolongation of QT/QTc interval 450 milliseconds at screening Other protocol-specified criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS): To evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone on overall survival (OS) in subjects with chemorefractory wild-type codons 12 and 13 Kirsten rat sarcoma viral oncogene homolog (KRAS wt) mCRC.Timepoint: [ Time Frame: Baseline to 8 months average ] [ Designated as safety issue: No ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR): The comparative incidence of either complete response (CR) or partial response (PR) per RECIST version 1.1 between panitumumab and best supportive care (BSC) versus BSC alone in RAS wt patients without mutation codons 12, 13, 59, 61, 117 and 146.Timepoint: [ Time Frame: 10 Weeks average ] [ Designated as safety issue: No ] ;Overall Survival (OS): To evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone in subjects with wild type RAS (without mutation in KRAS codon 12, 13, 59, 61, 117, and 163 or NRAS)Timepoint: [ Time Frame: 8 months average ] [ Designated as safety issue: No ] ;Progression Free Survival (PFS): To evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone in subjects with chemorefractory wild-type codons 12 and 13 Kirsten rat sarcoma viral oncogene homolog (KRAS) mCRC.Timepoint: [ Time Frame: 10 Weeks average ] [ Designated as safety issue: No ] ;Progression Free Survival (PFS): To evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone in subjects with wild type RAS (without mutation in KRAS codon 12, 13, 61, 117, 146 or NRAS)Timepoint: [ Time Frame: 10 Weeks average ] [ Designated as safety issue: No ] ;QTc Interval length amongst subjects treated with panitumumab as an indicator of effect on cardiac repolarisationTimepoint: [ Time Frame: week 7 ] [ Designated as safety issue: Yes ] ;Safety: Incidence of AEs, significant laboratory changes, and immunogenicityTimepoint: [ Time Frame: 10 Weeks average ] [ Designated as safety issue: Yes ] ;Objective Response Rate (ORR): The comparative incidence of either complete response (CR) or partial response (PR) per RECIST version 1.1 between panitumumab and best supportive care (BSC) versus BSC alone in KRAS wt patientsTimepoint: [ Time Frame: 10 Weeks average ] [ Designated as safety issue: No ] | — |
Countries
Canada, China, Croatia, Estonia, India, Latvia, Lithuania, Malaysia, Mexico, Peru, Philippines, Republic of Korea, Romania, Serbia
Contacts
Public ContactDr Veena Jaguste
Amgen Technology Pvt. Ltd
Outcome results
None listed