Phase I study of telatinib (BAY 57-9352): analysis of safety, pharmacokinetics, tumor efficacy, and biomarkers in patients with colorectal cancer
2011

Study of Telatinib in Colorectal Cancer Patients

Sample size: 39 publication Evidence: moderate

Author Information

Author(s): Klaus Mross, Annette Frost, Max E Scheulen, Jürgen Krauss, Dirk Strumberg, Beate Schultheiss, Ulrike Fasol, Martin Büchert, Jörn Krätzschmer, Heinz Delesen, Prabhu Rajagopalan, Olaf Christensen

Primary Institution: Tumor Biology Center at the Albert-Ludwigs-University Freiburg, Germany

Hypothesis

Is telatinib effective and safe for patients with refractory colorectal cancer?

Conclusion

Telatinib treatment was well tolerated, but showed limited antitumor activity in heavily pretreated colorectal cancer patients.

Supporting Evidence

  • Hypertension was the most common side effect, affecting 28% of patients.
  • 41% of patients experienced some tumor shrinkage during treatment.
  • No partial remission was observed according to RECIST criteria.

Takeaway

This study tested a new drug called telatinib on patients with colon cancer. While the drug was safe to use, it didn't work very well to shrink the tumors.

Methodology

A multicenter phase I dose-escalation study with 39 patients receiving telatinib at doses of ≥ 600 mg twice daily.

Potential Biases

Potential bias due to the non-randomized design and the small sample size.

Limitations

The study involved a small sample size and was limited to heavily pretreated patients.

Participant Demographics

39 Caucasian patients with refractory colorectal cancer, predominantly male (51%) with a mean age of 60.2 years.

Statistical Information

P-Value

0.0026

Statistical Significance

p=0.0026

Digital Object Identifier (DOI)

10.1186/2045-824X-3-16

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