Inhibition of DNA repair with MGMT pseudosubstrates: phase I study of lomeguatrib in combination with dacarbazine in patients with advanced melanoma and other solid tumours
2011

Study of Lomeguatrib and Dacarbazine in Melanoma Patients

Sample size: 41 publication Evidence: moderate

Author Information

Author(s): Tawbi H A, Villaruz L, Tarhini A, Moschos S, Sulecki M, Viverette F, Shipe-Spotloe J, Radkowski R, Kirkwood J M

Primary Institution: University of Pittsburgh Cancer Institute

Hypothesis

Can lomeguatrib combined with dacarbazine improve treatment outcomes in patients with advanced melanoma?

Conclusion

The recommended phase II dose of lomeguatrib is 40 mg orally twice daily for 10 days combined with 400 mg/m² of dacarbazine IV on day 2, but it significantly increases the toxicity of dacarbazine.

Supporting Evidence

  • 41 patients were enrolled in the study, with 36 having metastatic melanoma.
  • The most common side effects included nausea (52%) and fatigue (42%).
  • Only 1 patient had a partial response, while 10 had stable disease.

Takeaway

This study tested a new drug called lomeguatrib with another drug, dacarbazine, to see if it helps people with melanoma. It did help a little, but it also made people feel more sick.

Methodology

This was a phase I dose-escalation study to determine the maximum tolerated dose and recommended phase II dose of lomeguatrib combined with dacarbazine.

Limitations

The study had a small sample size and was limited to a single institution.

Participant Demographics

The majority of participants were patients with metastatic melanoma, with 61% having an ECOG performance status of 1.

Digital Object Identifier (DOI)

10.1038/bjc.2011.285

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