Phase I and pharmacokinetic study of the novel chemoprotector BNP7787 in combination with cisplatin and attempt to eliminate the hydration schedule
2005

Study of BNP7787 as a Chemoprotector with Cisplatin

Sample size: 46 publication Evidence: moderate

Author Information

Author(s): Boven E, Westerman M, van Groeningen C J, Verschraagen M, Ruijter R, Zegers I, van der Vijgh W J F, Giaccone G

Primary Institution: VU University Medical Center, Amsterdam, The Netherlands

Hypothesis

Can BNP7787 reduce the toxic effects of cisplatin while maintaining its efficacy?

Conclusion

BNP7787 was well tolerated and allowed for a significant reduction in saline hydration during cisplatin treatment.

Supporting Evidence

  • BNP7787 was tolerated well up to doses of 41 g/m2.
  • The recommended dose of 18.4 g/m2 enabled safe reduction of saline hydration to 1000 ml.
  • Partial tumor response was observed in four patients and stable disease in 15 patients.

Takeaway

This study tested a new drug called BNP7787 to see if it could help people getting another drug called cisplatin without making them sick. It worked well and helped reduce the amount of extra fluids needed.

Methodology

Patients with advanced solid tumors received BNP7787 in escalating doses followed by a fixed dose of cisplatin, with pharmacokinetics analyzed.

Limitations

The study was limited by the small sample size and the focus on short-term toxicity.

Participant Demographics

{"total_patients":46,"male_female_ratio":"14/11 in stage I, 14/7 in stage II","age_range":"37-70 years"}

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602553

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