ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2017-03-07
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Cetuximab; Panitumumab

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:

• 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 ≤ 30 days before randomization.

• Clinically significant cardiovascular disease

• Active infection requiring systemic treatment or any uncontrolled infection ≤14 days prior to randomization