Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study
2011

Safety and pharmacokinetics of motesanib with gemcitabine and erlotinib in solid tumors

Sample size: 56 publication 10 minutes Evidence: moderate

Author Information

Author(s): Dusan Kotasek, Niall Tebbutt, Jayesh Desai, Stephen Welch, Lillian L Siu, Sheryl McCoy, Yu-Nien Sun, Jessica Johnson, Adeboye H Adewoye, Timothy Price

Primary Institution: Adelaide Cancer Center

Hypothesis

The study aimed to assess the maximum tolerated dose, safety, and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib in patients with solid tumors.

Conclusion

Motesanib 100 mg QD plus erlotinib and gemcitabine was tolerable, while 125 mg QD was tolerable only with erlotinib alone.

Supporting Evidence

  • The maximum tolerated dose of motesanib in combination with gemcitabine and erlotinib was established as 100 mg QD.
  • Dose-limiting toxicities occurred in 11 patients across various cohorts.
  • One patient achieved a confirmed partial response, and 26 had stable disease.

Takeaway

Doctors tested a new cancer treatment combining three medicines to see if it was safe and how well it worked. They found one dose that was safe to use.

Methodology

Patients received gemcitabine and erlotinib alone or with different doses of motesanib, and the study monitored for dose-limiting toxicities and pharmacokinetics.

Limitations

The study was limited by the small sample size and the exploratory nature of tumor response assessments.

Participant Demographics

{"median_age":62,"sex_distribution":{"women":25,"men":31},"race_distribution":{"white":43,"asian":6}}

Digital Object Identifier (DOI)

10.1186/1471-2407-11-313

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