Safety and Pharmacokinetics of Motesanib with Panitumumab and Gemcitabine-Cisplatin in Advanced Cancer
Author Information
Author(s): Howard Burris, Joe Stephenson, Gregory A. Otterson, Mark Stein, Jesse McGreivy, Yu-Nien Sun, Megan Ingram, Yining Ye, Lee S. Schwartzberg
Hypothesis
The study aimed to assess the safety and tolerability of motesanib when administered in combination with panitumumab, gemcitabine, and cisplatin.
Conclusion
The combination of motesanib, panitumumab, and gemcitabine/cisplatin may be intolerable at the described doses and schedule, although some antitumor activity was observed.
Supporting Evidence
- 41 patients were enrolled and received treatment.
- The maximum tolerated dose was established as 100 mg QD.
- 10 patients had venous thromboembolic events related to motesanib treatment.
- One patient achieved a complete response and nine had partial responses.
- 29 out of 33 patients experienced motesanib-related adverse events.
Takeaway
Doctors wanted to see if a new medicine called motesanib could be safely used with other cancer treatments, but it turned out to be too hard for many patients to handle.
Methodology
This was an open-label, multicenter phase 1b study where patients received motesanib with panitumumab, gemcitabine, and cisplatin in 21-day cycles.
Potential Biases
There may be risks of bias due to the open-label design and the small sample size.
Limitations
The study was limited by a high incidence of thromboembolic events and the absence of a comparator group.
Participant Demographics
The most common tumor type was non-small-cell lung cancer (51%), with 85% of patients having stage IV disease.
Statistical Information
Confidence Interval
95% CI, 12.4–40.3
Digital Object Identifier (DOI)
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