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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01412957
First received: March 31, 2011
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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 subjects with chemorefractory wild-type KRAS metastatic colorectal cancer.


Condition Intervention Phase
Metastatic Colorectal Cancer
Other: Best Supportive Care
Drug: Panitumumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Open-label Trial to Evaluate the Survival Benefit of Panitumumab and Best Supportive Care, Compared to Best Supportive Care Alone, in Subjects With Chemorefractory Wild-type KRAS Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Amgen:

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. [ Time Frame: Baseline to 8 months average ] [ Designated as safety issue: No ]

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) [ Time Frame: 10 Weeks average ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 10 Weeks average ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 10 Weeks average ] [ Designated as safety issue: No ]
  • Effcacy : To evaluate Objective Response Rate (ORR) among subjects with wild type exon 2 (codons 12 and 13) KRAS tumours [ Time Frame: 10 Weeks average ] [ Designated as safety issue: No ]
  • Safety: Incidence of AEs, significant laboratory changes, and immunogenicity [ Time Frame: 10 Weeks average ] [ Designated as safety issue: Yes ]
  • QTc Interval length amongst subjects treated with panitumumab as an indicator of effect on cardiac repolarisation [ Time Frame: week 7 ] [ Designated as safety issue: Yes ]
  • 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) [ Time Frame: 8 months average ] [ Designated as safety issue: No ]

Enrollment: 377
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pmab + BSC
Panitumumab (administered intravenously 6 mg/kg every 14 days) plus BSC
Drug: Panitumumab
Panitumumab administered intravenously 6 mg/kg every 14 days.
BSC Alone
Best Supportive Care
Other: Best Supportive Care
Best supportive care treatment as determined by the investigator.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of metastatic colorectal cancer
  • Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory
  • ECOG performance status of 0, 1 or 2
  • At least 1 measurable or non-measurable lesion per 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-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 QTc Evaluation Subpart of the Study: Prolongation of QT/QTc interval > 450 milliseconds at screening
  • Other protocol-specified criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412957

  Show 78 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01412957     History of Changes
Other Study ID Numbers: 20100007
Study First Received: March 31, 2011
Last Updated: June 6, 2014
Health Authority: EU: CHMP
United States: Food and Drug Administration

Keywords provided by Amgen:
Best Supportive Care
Panitumumab
Chemorefractory
Wild-type KRAS
Overall Survival
Phase 3

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014