Phase I and pharmacokinetic study of DACA (XR5000): a novel inhibitor of topoisomerase I and II
1999

Study of DACA (XR5000) as a Cancer Treatment

Sample size: 41 publication Evidence: low

Author Information

Author(s): Twelves C J, Gardner C, Flavin A, Sludden J, Dennis I, Bono J de, Beale P, Vasey P, Hutchison C, Macham M A, Rodriguez A, Judson I, Bleehen N M

Primary Institution: CRC Department of Medical Oncology, Alexander Stone Building, Glasgow, Bearsden, G61 1BD, UK

Hypothesis

Can DACA (XR5000) be safely administered to patients and what are its pharmacokinetics?

Conclusion

DACA was found to have a unique toxicity profile and showed no objective responses in patients.

Supporting Evidence

  • DACA was administered to 41 patients at 11 different dose levels.
  • The most common side effect was pain during the infusion.
  • There was one minor response but no objective responses were observed.
  • DACA's pharmacokinetics were linear and consistent across treatment days.

Takeaway

Doctors tested a new cancer drug called DACA on 41 patients, but it didn't work well and caused some unusual side effects.

Methodology

DACA was given as a 3-hour intravenous infusion on 3 successive days, repeated every 3 weeks.

Limitations

The study had a small sample size and only one minor response was observed.

Digital Object Identifier (DOI)

10.1038/sj.bjc.6690598

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