Phase I and pharmacological study of the farnesyltransferase inhibitor tipifarnib (Zarnestra®, R115777) in combination with gemcitabine and cisplatin in patients with advanced solid tumours
2005

Study of Tipifarnib with Gemcitabine and Cisplatin in Cancer Patients

Sample size: 31 publication 10 minutes Evidence: moderate

Author Information

Author(s): Siegel-Lakhai W S, Crul M, Zhang S, Sparidans R W, Pluim D, Howes A, Solanki B, Beijnen J H, Schellens J H M

Primary Institution: The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital

Hypothesis

The study aimed to determine the safety and maximum tolerated dose of tipifarnib in combination with gemcitabine and cisplatin in patients with advanced solid tumors.

Conclusion

Tipifarnib can be safely administered at a dose of 200 mg twice daily in combination with gemcitabine and cisplatin, showing evidence of antitumor activity.

Supporting Evidence

  • Eight patients had a confirmed partial response.
  • Twelve patients had stable disease for more than 8 weeks.
  • Major and clinically relevant drug-drug interactions were not evident.

Takeaway

Doctors tested a new cancer treatment combining three drugs to see if it was safe and effective, and they found it worked well for some patients.

Methodology

Patients received tipifarnib, gemcitabine, and cisplatin in a dose-escalation study to determine safety and pharmacokinetics.

Potential Biases

There may be bias due to the study being sponsored by a pharmaceutical company.

Limitations

The study was limited by the small sample size and the potential for overlapping toxicities among the drugs.

Participant Demographics

The study included 31 patients, 14 male and 17 female, with a median age of 58 years.

Statistical Information

P-Value

p<0.05

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602850

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