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Study Complete
Sponsor ID
20080763

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

Sponsor ID
20080763
Clinicaltrials.gov ID
NCT01001377
EUCTIS ID
N/A
EudraCT ID
2009-010715-32
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
panitumumab
Type
Interventional
Masking
None (Open Label)
Enrollment
1010
Additional Study Details

Protocol Summary

Primary Outcome Measures

To compare the effect of panitumumab versus cetuximab on overall survival for chemorefractory mCRC among subjects with wild-type KRAS tumors.

Timeframe: 4 years

Secondary Outcome Measures

To compare safety of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

Timeframe: 4 years

To compare patient reported outcomes of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

Timeframe: 4 years

To compare progression-free survival of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

Timeframe: 4 years.

To compare objective response rate of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

Timeframe: 4 years

To compare time to response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

Timeframe: 4 years

To compare time to treatment failure of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

Timeframe: 4 years

To compare duration of response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

Timeframe: 4 years

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Box Hill, VIC, Australia, 3128
Status
Recruiting
Location
Research Site
Footscray, VIC, Australia, 3011
Status
Recruiting
Location
Research Site
Parkville, VIC, Australia, 3050
Status
Recruiting
Location
Research Site
Wollongong, NSW, Australia, 2500
Status
Recruiting
Location
Research Site
Woodville South, SA, Australia, 5011
Status
Recruiting
Location
Research Site
Epping, VIC, Australia, 3076
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Colorectal Cancer
    • Sex
    All
    Trial Dates
    Feb 2010 - Feb 2013
    Inclusion and Exclusion 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