18 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Rate of ResponsePrimary· 4 months
Rate of response is defined as the percentage of participants with a complete response (CR) + partial response (PR) + stable disease (SD) for 4 months. Response is defined by the Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response is a disappearance of all target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), ta
Group
Value
95% CI
BAY 43-9006 & Cetuximab
15
Count of Participants With Adverse EventsSecondary· 96 months, 26 days
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Group
Value
95% CI
BAY 43-9006 & Cetuximab
50
Adverse events — posted to ClinicalTrials.gov
Time frame: 96 months, 26 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
BAY 43-9006 & Cetuximab
Serious: 22/50 (44%)
Deaths: 2/50
Serious adverse events (31 terms)
Reaction
System
BAY 43-9006 & Cetuximab
Small intestinal obstruction
Gastrointestinal disorders
—
Fever
General disorders
—
Abdominal distension
Gastrointestinal disorders
—
Anemia
Blood and lymphatic system disorders
—
Bladder infection
Infections and infestations
—
Death NOS
General disorders
—
Headache
Nervous system disorders
—
Vomiting
Gastrointestinal disorders
—
Anaphylaxis
Immune system disorders
—
Back pain
Musculoskeletal and connective tissue disorders
—
Blood bilirubin increased
Investigations
—
Catheter related infection
Infections and infestations
—
Chills
General disorders
—
Dehydration
Gastrointestinal disorders
—
Diarrhea
Gastrointestinal disorders
—
Duodenal obstruction
Gastrointestinal disorders
—
Hematuria
Renal and urinary disorders
—
Hypokalemia
Metabolism and nutrition disorders
—
Hyponatremia
Metabolism and nutrition disorders
—
Ileus
Gastrointestinal disorders
—
Ischemia cerebrovascular
Nervous system disorders
—
Lipase increased
Investigations
—
Movements involuntary
Nervous system disorders
—
Nausea
Gastrointestinal disorders
—
Pain
General disorders
—
Other adverse events (144 terms — click to expand)
Background:
* Colorectal cancer (CRC) is a major public health problem in the U.S. and worldwide, and 5-year survival with widespread metastatic disease is less than 5%.
* Expression of epidermal growth factor receptor (EGFR) or up-regulation of the gene occurs in the majority of CRC cases (60-80%).
* Therapies targeting EGFR, like cetuximab, have shown activity in the treatment of solid tumors like CRC.
* Cetuximab is FDA (Food and Drug Administration) approved for the treatment of EGFR-expressing CRC, but clinical responses to cetuximab are seen in only 10% of EGFR-expressing CRC.
* One possible mechanism of resistance to cetuximab could be KRAS (Kirsten rat sarcoma) mutations.
* Another major pathway implicated in colon carcinogenesis is the vascular endothelial growth factor (VEGF) pathway, which is involved in angiogenesis and is a validated target for therapy in CRC.
* BAY 43-9006 is both a Raf kinase inhibitor and an inhibitor of VEGF receptor (VEGFR2) tyrosine kinase.
* We hypothesize that the combined inhibition of EGFR, VEGFR2, and the Ras-(rapidly accelerated fibrosarcoma) Raf pathway will demonstrate promising clinical activity in CRC. Furthermore, in patients with mutant KRAS, combination of cetuximab with a drug that inhibits Raf kinase and acts downstream of Ras mutations, could restore tumor sensitivity to cetuximab.
Objectives:
* To determine the rate of response (complete response (CR) + partial response (PR) + stable disease (SD) for 4 months) and toxicity profile of combination of BAY 43-9006 and cetuximab in previously treated EGFR-expressing metastatic CRC in patients with mutant KRAS.
* To evaluate BAY 43-9006 pharmacokinetics \& pharmacogenomics (CYP3A4/5 (cytochrome P450 3A4/5)).
* To evaluate for this combination treatment pharmacodynamics, effect on tumor vascularity and effect on angiogenic cytokines.
Eligibility:
* Adults with histologically or cytologically documented, measurable, EGFR-expressing metastatic CRC, which has recurred or progressed following at least one prior 5FU (Fluorouracil)-based combination chemotherapy regimen administered for the treatment of metastatic disease.
* Patients must be KRAS mutation-positive.
Design:
* BAY 43-9006 will be administered 400 mg by mouth twice daily
* Cetuximab will be administered as 400 mg/m\^2 loading dose (week 1) followed by 250 mg/m\^2 IV (intravenous) weekly.
* If procedure may be performed safely, tumor biopsy will be obtained prior to treatment and after 4 weeks of treatment.
* Optional positron emission tomography (PET)/computerized tomography (CT) imaging with 89Zr-labeled, EGFR-targeting antibody panitumumab may be performed to evaluate radiation dosimetry, safety, and tumor distribution prior to and following treatment with study agents.
* Patients will be evaluated for response every 8 weeks using the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
* This trial uses a phase II optimal design targeting a response rate as defined above of 20% in patients with mutant KRAS. Up to 49 patients may be treated.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 24 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00326495.