Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer

Amgen

Status and phase: Completed; Phase 3

Conditions: Metastatic Colorectal Cancer

Treatments: Other: Best Supportive Care (BSC); Drug: Panitumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01412957

20100007

2010-022951-49 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.

Enrollment: 377 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of metastatic colorectal cancer (CRC)

• Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

• At least 1 measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (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 subject's legally acceptable representative has provided informed consent.

• Other protocol-specified criteria may apply

Exclusion criteria

• Symptomatic brain metastases requiring treatment
• History of another primary cancer within 5 years of randomization
• 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) within 21 days before randomization
• Radiotherapy within 14 days before randomization.
• Exclusion Criteria for corrected QT (QTc) Evaluation Subpart of the Study: Prolongation of QT/QTc interval > 450 milliseconds at screening
• Other protocol-specified criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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377 participants in 2 patient groups

Panitumumab + BSC

Experimental group

Description:

Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus BSC until disease progression, withdrawal of consent, death, or intolerance of study drug.

Treatment:

Drug: Panitumumab

Other: Best Supportive Care (BSC)

BSC Alone

Other group

Description:

Participants received best supportive care until disease progression, withdrawal of consent, or death.

Treatment:

Other: Best Supportive Care (BSC)