A Phase I clinical and pharmacological study of cis-diamminedichloro(2-methylpyridine) platinum II (AMD473)
2003

Study of AMD473, a New Platinum Drug

Sample size: 42 publication Evidence: moderate

Author Information

Author(s): Beale P, Judson I, O'Donnell A, Trigo J, Rees C, Raynaud F, Turner A, Simmons L, Etterley L

Primary Institution: Royal Marsden Hospital

Hypothesis

AMD473 is designed to overcome platinum resistance in cancer treatment.

Conclusion

AMD473 shows promise in treating patients with platinum-resistant tumors and has a manageable toxicity profile.

Supporting Evidence

  • AMD473 was able to overcome resistance in cell lines with high levels of glutathione.
  • The maximum tolerated dose in preclinical studies was determined to be 45 mg/kg.
  • Antitumour activity was noted in several tumour models including human ovarian carcinoma xenografts.
  • Patients with a good performance status tolerated higher doses with minimal added toxicity.
  • Thrombocytopenia was the most commonly observed toxicity in the study.

Takeaway

AMD473 is a new medicine that helps treat cancer, especially when other treatments don't work anymore.

Methodology

This was an open-label, dose-escalating, single-centre Phase I trial to determine the maximum tolerated dose and pharmacokinetics of AMD473.

Potential Biases

Potential bias due to the single-centre design and the open-label nature of the trial.

Limitations

The study was limited by the heavily pretreated patient population and the small sample size.

Participant Demographics

{"gender":{"male":16,"female":26},"age":{"median":53,"range":"33-71"},"tumour_types":{"ovary":10,"nonsmall_cell_lung":9,"mesothelioma":7,"head_and_neck":6,"colon":3,"other":7}}

Statistical Information

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6600854

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