Phase 3
Completed N=1,010
ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT01001377 ↗Enrolled (actual)
1,010
Serious AEs
32.0%
Results posted
Mar 2014
Primary outcomePrimary: Overall Survival — 10.0; 10.4 months — p=0.0007
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
10.0; 10.4 | 0.0007 sig |
| SECONDARY Progression-free Survival |
4.4; 4.1 | — |
| SECONDARY Objective Response |
19.79; 22.02 | — |
| SECONDARY Duration of Response |
5.4; 3.8 | — |
| SECONDARY Time to Response |
2.6; 1.5 | — |
| SECONDARY Time to Treatment Failure |
3.3; 3.4 | — |
| SECONDARY Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score |
-0.0341; -0.0216 | — |
| SECONDARY Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS) |
3.9782; 2.3037 | — |
| SECONDARY Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score |
2.0101; 3.0473 | — |
| SECONDARY Change From Baseline in NCCN FCSI Physical Well-being Scale Score |
1.8778; 2.4614 | — |
| SECONDARY Change From Baseline in NCCN FCSI Functional Well-being Scale Score |
1.3567; 1.1569 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
494; 485; 169; 151; 61; 69 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01001377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.