A Phase 2 interventional study of Panitumumab in Metastatic Colorectal Cancer, sponsored by National Cancer Institute, Naples. Status unknown at 5 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by National Cancer Institute, Naples · Phase 2, Interventional, and Treatment
The purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.
The study was amended with modification of inclusion criteria (from wild-type tumor KRAS gene to wild-type RAS gene, including KRAS and NRAS exons 2, 3 and 4)
RAS mutational status of tumors of patients enrolled before amendment 1 approval will be centrally revised. Patients whose tumors will result RAS mutated at the biomarkers central revision, will be replaced. Therefore, the overall sample size at both the stages may be higher than the one initially planned.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 52 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →National Cancer Institute, Naples is the lead sponsor of 112 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Panitumumab
6mg/kg IV given every 2 weeks until disease progression or unacceptable toxicity
number of patients alive and without disease progression
progression of disease within 2 months from registration according to RECIST criteria, and death for any cause within 2 months from registration
Time frame: 2 months
response rate
Response assessed per patients at weeks 8,16,24,32,40 and every 3 months thereafter, using RECIST criteria
Time frame: up to 40 weeks
progression free survival
Time frame: 9 months
overall survival
Time frame: one year
worst grade toxicity per patient
worst grade toxicity (according to Common Terminology Criteria for Adverse Events version 3) per patient
Time frame: every 2 weeks for up to 6 months
gene expression on tumor tissue
exploratory analysis of tumor-tissue for biological or genomic determinants of outcome of BRAF and P13K mutation status, EGFR and PTEN expression status
Time frame: one year
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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National Cancer Institute, Naples