Phase I dose escalation study of telatinib (BAY 57-9352) in patients with advanced solid tumours
2008

Study of Telatinib in Patients with Advanced Solid Tumors

Sample size: 71 publication Evidence: moderate

Author Information

Author(s): Strumberg D, Schultheis B, Adamietz I A, Christensen O, Buechert M, Kraetzschmar J, Rajagopalan P, Ludwig M, Frost A, Steinbild S, Scheulen M E, Mross K

Primary Institution: University of Bochum (Marien Hospital, Herne), Herne, Germany

Hypothesis

The study aims to determine the maximum-tolerated dose and pharmacokinetics of telatinib in patients with advanced solid tumors.

Conclusion

Telatinib is safe and well tolerated up to a dose of 1500 mg BID continuous dosing, with some patients showing partial responses.

Supporting Evidence

  • Hypertension (23%) and diarrhoea (7%) were the most frequent study drug-related adverse events.
  • Two renal cell carcinoma patients reached a partial response.
  • Telatinib was rapidly absorbed with a median tmax of 3 hours or less.
  • The maximum-tolerated dose was not reached up to a dose of 1500 mg BID continuous dosing.

Takeaway

This study tested a new cancer drug called telatinib to see how much can be safely given to patients with tough-to-treat tumors, and it found that the drug is mostly safe and can help some patients.

Methodology

This was a multicentre, open-label, non-controlled, phase I dose escalation study.

Limitations

The study did not reach the maximum-tolerated dose, and the sample size may limit the generalizability of the findings.

Participant Demographics

71 patients (30 women, 41 men) with a median age of 60 years.

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604724

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