Safety and pharmacokinetics of motesanib in combination with gemcitabine for the treatment of patients with solid tumours
2008

Safety and pharmacokinetics of motesanib with gemcitabine in cancer treatment

Sample size: 26 publication Evidence: moderate

Author Information

Author(s): Price T J, Lipton L, McGreivy J, McCoy S, Sun Y-N, Rosenthal M A

Primary Institution: The Queen Elizabeth Hospital

Hypothesis

The study aims to assess the safety and pharmacokinetics of motesanib in combination with gemcitabine for patients with advanced solid tumours.

Conclusion

The combination of motesanib and gemcitabine was well tolerated, with a similar safety profile to that observed in monotherapy studies.

Supporting Evidence

  • Twenty-six patients were enrolled and received motesanib and gemcitabine.
  • No dose-limiting toxicities occurred during the study.
  • Sixteen patients experienced motesanib-related adverse events, with lethargy being the most common.
  • The objective response rate was 4%, and 27% of patients achieved stable disease.

Takeaway

Doctors tested a new medicine called motesanib with another medicine called gemcitabine to see if it was safe for people with certain types of cancer, and it turned out to be safe.

Methodology

This was an open-label phase 1b study with three sequential, dose-escalating cohorts of patients receiving different doses of motesanib in combination with gemcitabine.

Limitations

The small sample size limits the interpretation of efficacy results.

Participant Demographics

{"age_range":"25-77","gender_distribution":{"male":14,"female":12},"most_common_tumor_types":["soft tissue sarcoma","ovarian","pancreatic","neuroendocrine"]}

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604723

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