Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer
This study is currently recruiting participants.
Verified April 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01412957
First received: March 31, 2011
Last updated: April 23, 2013
Last verified: April 2013
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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:
- Overall Survival (OS): To evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone on overall survival (OS) in subjects with chemorefractory wild-type 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:
- Progression Free Survival (PFS): To evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone in subjects with wild type RAS (without mutation in KRAS codon 12, 13, 61, or NRAS) [ Time Frame: 10 Weeks average ] [ Designated as safety issue: No ]
- Objective Response Rate (ORR): The comparative incidence of either complete response (CR) or partial response (PR) per RECIST version 1.1 between panitumumab and best supportive care (BSC) versus BSC alone in KRAS wt patients [ Time Frame: 10 Weeks average ] [ Designated as safety issue: No ]
- Progression Free Survival (PFS): To evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone in subjects with chemorefractory wild-type codons 12 and 13 Kirsten rat sarcoma viral oncogene homolog (KRAS) mCRC. [ Time Frame: 10 Weeks average ] [ Designated as safety issue: No ]
- Objective Response Rate (ORR): The comparative incidence of either complete response (CR) or partial response (PR) per RECIST version 1.1 between panitumumab and best supportive care (BSC) versus BSC alone in RAS wt patients [ 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 ]
- Overall Survival (OS): To evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone in subjects with wild type RAS (without mutation in KRAS codon 12, 13, 61, or NRAS) [ Time Frame: 8 months average ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 350 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | March 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412957
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Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Show 74 Study LocationsSponsors 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: | April 23, 2013 |
| 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 May 21, 2013