A phase I pharmacokinetic and pharmacodynamic study of BGC9331 and carboplatin in relapsed gynaecological malignancies
2005

Study of BGC9331 and Carboplatin in Ovarian Cancer

Sample size: 14 publication Evidence: moderate

Author Information

Author(s): Benepal T, Jackman A, Pyle L, Bate S, Hardcastle A, Aherne W, Mitchell F, Simmons L, Ruddle R, Raynaud F, Gore M

Primary Institution: The Royal Marsden Hospital

Hypothesis

The combination of BGC9331 and carboplatin will be well tolerated and show antitumor activity in patients with relapsed gynaecological malignancies.

Conclusion

The combination of BGC9331 and carboplatin is well tolerated with evidence of antitumor activity in platinum-pretreated gynaecological malignancies.

Supporting Evidence

  • 28% of patients showed antitumor activity.
  • Two patients experienced dose-limiting toxicities at the highest dose level.
  • Plasma deoxyuridine levels indicated thymidylate synthase inhibition.

Takeaway

This study tested a new drug combination for ovarian cancer and found it to be safe and effective for some patients.

Methodology

This was a phase I dose escalation study where patients received varying doses of BGC9331 and a fixed dose of carboplatin, with assessments of toxicity and antitumor activity.

Limitations

The study had a small sample size and was limited to patients who had previously been treated with platinum-based therapies.

Participant Demographics

The median age of participants was 51 years, with a range of 44 to 64 years, and all had a performance status of 0 or 1.

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602811

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