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