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Study Complete
Sponsor ID
20100007

Comparison of survival benefit of panitumumab with supportive care to best supportive care alone in patients with metastatic colorectal cancer

Sponsor ID
20100007
Clinicaltrials.gov ID
NCT01412957
EUCTIS ID
N/A
EudraCT ID
2010-022951-49
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
panitumumab
Type
Interventional
Masking
None (Open Label)
Enrollment
377
Additional Study Details

Protocol Summary

Primary Outcome Measures

To evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone on overall survival (OS) in subjects with chemorefractory wild-type exon 2 (codons 12 and 13) Kirsten rat sarcoma viral oncogene homolog (KRAS wt) mCRC.

Timeframe: Baseline to 8 months average

Secondary Outcome Measures

Efficacy: Evaluate Progression Free Survival (PFS) among subjects with wild-type RAS (without mutation in exons 2 [codons 12, 13], 3 [59 and 61] and 4 [codons 117 and 146] of KRAS or NRAS)

Timeframe: 10 Weeks average

Efficacy: To evaluate Objective Response Rate (ORR) among subjects with wild-type RAS tumours (without mutation in exons 2 [codons 13 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS or NRAS)

Timeframe: 10 Weeks average

Efficacy: To evaluate Progression Free Survival (PFS) in subjects with chemorefractory wild-type exon 2 (codons 12 and 13) Kirsten rat sarcoma viral oncogene homolog (KRAS) mCRC.

Timeframe: 10 Weeks average

Effcacy : To evaluate Objective Response Rate (ORR) among subjects with wild type exon 2 (codons 12 and 13) KRAS tumours

Timeframe: 10 Weeks average

Safety: Incidence of AEs, significant laboratory changes, and immunogenicity

Timeframe: 10 Weeks average

QTc Interval length amongst subjects treated with panitumumab as an indicator of effect on cardiac repolarisation

Timeframe: week 7

Efficacy: To evaluate Overall Survival (OS) among subjects with wild-type RAS tumours (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS or neuroblasta RAS viral oncogene (NRAS)

Timeframe: 8 months average

Study Documents

Study Synopsis
Available Language(s): English
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Plain Language Summary of Results
Available Language(s): French (Canadian), Hindi, Latvian, Kannada, Greek, Lithuanian, Malay, Portuguese, Romanian, Russian, Russian, Serbian, Chinese (Simplified), Chinese (Simplified), Spanish (Latin America), Spanish, Cebuano, Korean, Tagalog, Croatian, Estonian, Marathi, Tamil, Malayalam, Tamil, Telugu, Cebuano, Urdu, English
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Locations

Location
Status
Contact Us
Location
Research Site
Montreal, QC, Canada, H1T 2M4
Status
Completed
Location
Research Site
Montreal, QC, Canada, H4J 1C5
Status
Recruiting
Location
Research Site
Greenfield Park, QC, Canada, J4V 2H1
Status
Completed
Location
Research Site
Quebec, QC, Canada, G1R 2J6
Status
Completed
Location
Research Site
Zagreb, Croatia, 10000
Status
Recruiting
Location
Research Site
Pula, Croatia, 52100
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Colorectal Cancer
    • Sex
    All
    Trial Dates
    Nov 2011 - Jun 2014
    Inclusion and Exclusion Criteria
    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. o 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