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

Completed · Phase 3

Conditions studied: Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT01001377

Run by

Amgen

People needed

1010

Starts

2010-02-02

Expected to finish

2017-03-07

Last updated by the study team

2022-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Boynton Beach, Florida, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Temple, Texas, United States
• Research Site — Ogden, Utah, United States
• Research Site — Liverpool, New South Wales, Australia
• Research Site — St Leonards, New South Wales, Australia
• Research Site — Wahroonga, New South Wales, Australia
• Research Site — Wollongong, New South Wales, Australia
• Research Site — Woodville South, South Australia, Australia
• Research Site — Ballarat, Victoria, Australia
• Research Site — Box Hill, Victoria, Australia
• Research Site — Epping, Victoria, Australia
• Research Site — Footscray, Victoria, Australia
• Research Site — Heidelberg, Victoria, Australia
• Research Site — Parkville, Victoria, Australia
• Research Site — Edegem, Belgium
• Research Site — Sofia, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Edmonton, Alberta, Canada
• Research Site — Halifax, Nova Scotia, Canada
• Research Site — Guangzhou, Guangdong, China
• Research Site — Guangzhou, Guangdong, China
• Research Site — Guangzhou, Guangdong, China
• Research Site — Guangzhou, Guangdong, China
• Research Site — Stockton, California, United States

Full record on ClinicalTrials.gov

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