ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Subjects With KRAS Wild-Type Metastatic Colorectal Cancer
This study is currently recruiting participants.
Verified May 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01001377
First received: October 22, 2009
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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 subjects with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Colorectal Cancer |
Drug: Cetuximab (Erbitux) Drug: Panitumumab (Vectibix) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects With Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- To compare the effect of panitumumab versus cetuximab on overall survival for chemorefractory mCRC among subjects with wild-type KRAS tumors. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare safety of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- To compare patient reported outcomes of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- To compare progression-free survival of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors. [ Time Frame: 4 years. ] [ Designated as safety issue: No ]
- To compare objective response rate of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- To compare time to response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- To compare time to treatment failure of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- To compare duration of response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | September 2014 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cetuximab
Cetuximab 400 mg/m2 as an initial dose, followed by 250 mg/m2 IV every 7 days
|
Drug: Cetuximab (Erbitux)
400 mg/m2 as an initial dose, followed by 250 mg/m2 IV every 7 days
|
|
Experimental: Panitumumab
Panitumumab (Vectibix) 6 mg/kg IV every 14 days
|
Drug: Panitumumab (Vectibix)
6 mg/kg IV every 14 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001377
Show 155 Study Locations
Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Show 155 Study LocationsSponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01001377 History of Changes |
| Other Study ID Numbers: | 20080763, ASPECCT |
| Study First Received: | October 22, 2009 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Quorom Institutional Review Board India: Central Drugs Standard Control Organization South Korea: Korea Food & Drug Administration Taiwan: Department of Health South Africa: Department of Health Serbia: Medicine and Medical Devices Agency of Serbia Peru: Ministry of Health United States: Institutional Review Board Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicines and Health Products, FAMHP Canada: Health Canada Czech Republic: State Institute for Drug Control EU: CHMP France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Hong Kong: Department of Health Italy: Ethics Committee Latvia: State Agency of Medicines Lithuania: State Medicines Control Agency of Lithuania Malaysia: National Pharmaceutical Control Bureau Netherlands:Centrale Commissie Mensgebonden Onderzoek (CCMO) Phillippines: the Bureau of Food and Drugs Poland: Ministry of Health Russia: Ministry of Health of the Russian Federation Singapore: Health Science Authority Slovakia: State Institiute for Drug Control South Korea: Korea Food and Drug Administration Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Panitumumab Vectibix Colon Cancer Colorectal Cancer |
Rectal Cancer Cetuximab Erbitux Metastatic |
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 Cetuximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013