Phase I dose-escalation study to determine the safety, pharmacokinetics and pharmacodynamics of brivanib alaninate in combination with full-dose cetuximab in patients with advanced gastrointestinal malignancies who have failed prior therapy
2011

Study on Brivanib and Cetuximab for Advanced Gastrointestinal Cancer

Sample size: 62 publication Evidence: moderate

Author Information

Author(s): Garrett C R, Siu L L, El-Khoueiry A, Buter J, Rocha-Lima C M, Marshall J, LoRusso P, Major P, Chemidlin J, Mokliatchouk O, Velasquez L, Hayes W, Feltquate D, Syed S, Ford S, Kollia G, Galbraith S, Nuyten D S A

Primary Institution: The University of Texas MD Anderson Cancer Center

Hypothesis

The study aims to determine the safety, pharmacokinetics, pharmacodynamics, and efficacy of brivanib combined with full-dose cetuximab in patients with advanced gastrointestinal malignancies.

Conclusion

The study found that brivanib combined with cetuximab has an acceptable toxicity profile and shows promising efficacy in patients with advanced gastrointestinal cancer.

Supporting Evidence

  • 6 patients (9.7%) had objective radiographic partial responses.
  • The median duration of response was 9.2 months.
  • The median progression-free survival was 3.9 months.
  • Brivanib treatment-related adverse events were manageable.
  • 14 patients died during the study, primarily due to disease progression.

Takeaway

This study tested a new cancer treatment combining two drugs, and it showed that the treatment is safe and might help some patients.

Methodology

Patients received brivanib and cetuximab, and their responses were assessed through various clinical evaluations and imaging techniques.

Limitations

The maximum tolerated dose was not reached, and the study population was heavily pretreated, which may limit the generalizability of the results.

Participant Demographics

The majority of participants were male (61%), with a median age of 60 years, primarily diagnosed with colorectal cancer.

Statistical Information

Confidence Interval

95% CI: 7.20, 16.4 months for median duration of response; 95% CI: 3.38, 5.42 months for median progression-free survival.

Digital Object Identifier (DOI)

10.1038/bjc.2011.182

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