Phase 3 clinical Study to Compare the Efficacy and Safety of drug product Panitumumab and Cetuximab in Subjects with Previously Treated Metastatic Colorectal Cancer.

A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects with Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000277

Enrollment

1000

Registered

2010-03-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C189- Malignant neoplasm of colon, unspecified Health Condition 2: C20- Malignant neoplasm of rectum Health Condition 3: null- Metastatic Colorectal Cancer

Interventions

Intervention1: Panitumumab (Vectibix): 6 mg/kg IV every 14 days Control Intervention1: Cetuximab active comparator: Cetuximab (Erbitux) 400mg/m2 as an initial dose, followed by 250mg/m2 IV every seven

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum, metastatic disease Wild-type KRAS tumor status Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 Must have failed a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of colorectal cancer (CRC) Adequate hematologic, renal, hepatic and metabolic function

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Symptomatic brain metastases requiring treatment Prior anti-epidermal growth factor receptor (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, radiotherapy), or investigational agent or therapy ¡Ü 30 days before randomization. Clinically significant cardiovascular disease Active infection requiring systemic treatment or any uncontrolled infection ¡Ü14 days prior to randomization

Design outcomes

Primary

Measure	Time frame
To compare the effect of panitumumab versus cetuximab on overall survival for chemorefractory mCRC among subjects with wild-type KRAS tumors. Timepoint: [ Time Frame: 4 years ] [ Designated as safety issue: No ]	—

Secondary

Measure	Time frame
To compare duration of response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.Timepoint: [ Time Frame: 4 years ] [ Designated as safety issue: No ] ;To compare objective response rate of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.Timepoint: [ Time Frame: 4 years ] [ Designated as safety issue: No ] ;To compare patient reported outcomes of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors. Timepoint: [ Time Frame: 4 years ] [ Designated as safety issue: Yes ] ;To compare progression-free survival of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.Timepoint: [Time Frame: 4 years. ] [ Designated as safety issue: No ] ;To compare safety of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.Timepoint: [ Time Frame: 4 years ] [ Designated as safety issue: Yes ] ;To compare time to response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.Timepoint: [ Time Frame: 4 years ] [ Designated as safety issue: No ] ;To compare time to treatment failure of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.Timepoint: [ Time Frame: 4 years ] [ Designated as safety issue: No ]	—

Measure

Time frame

To compare duration of response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.Timepoint: [ Time Frame: 4 years ] [ Designated as safety issue: No ] ;To compare objective response rate of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.Timepoint: [ Time Frame: 4 years ] [ Designated as safety issue: No ] ;To compare patient reported outcomes of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors. Timepoint: [ Time Frame: 4 years ] [ Designated as safety issue: Yes ] ;To compare progression-free survival of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.Timepoint: [Time Frame: 4 years. ] [ Designated as safety issue: No ] ;To compare safety of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.Timepoint: [ Time Frame: 4 years ] [ Designated as safety issue: Yes ] ;To compare time to response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.Timepoint: [ Time Frame: 4 years ] [ Designated as safety issue: No ] ;To compare time to treatment failure of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.Timepoint: [ Time Frame: 4 years ] [ Designated as safety issue: No ]

—

Countries

Australia, Belgium, Canada, Czech Republic, Democratic People's Republic of Korea, France, India, Italy, Latvia, Lithuania, Malaysia, Netherlands, Peru, Philippines, Poland, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Sweden, Taiwan, United Kingdom, United States of America

Contacts

Public ContactDr Veena Jaguste

Amgen Technology Pvt. Ltd

avirkar@amgen.com91-22-67869303

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026