Phase I Trial of CB10-277 for Cancer Treatment
Author Information
Author(s): B.J. Foster, D.R. Newell, L.A. Gumbrell, K.E. Jenns, A.H. Calvert
Primary Institution: Institute of Cancer Research and Royal Marsden Hospital
Hypothesis
Can a 24-hour continuous infusion of CB10-277 reduce toxicity while maintaining efficacy in cancer patients?
Conclusion
The 24-hour continuous infusion of CB10-277 was better tolerated than short infusion and produced acceptable myelosuppression.
Supporting Evidence
- The dose limiting toxicity was myelosuppression, with manageable nausea and vomiting.
- Pharmacokinetic studies showed a mean half-life of 178 minutes for the parent drug.
- The recommended Phase II dose was determined to be 12,000 mg/m2.
- Responses included one mixed response in a patient with recurrent melanoma.
Takeaway
Doctors tested a new way to give a cancer drug to make it easier for patients, and it worked better than the old way.
Methodology
Twenty-two patients received 42 courses of CB10-277 via 24-hour continuous infusion, with pharmacokinetic studies performed on 13 courses.
Limitations
The small sample size limits the ability to draw firm conclusions about efficacy.
Participant Demographics
Median age was 55 years, with 8 females and 14 males.
Statistical Information
P-Value
<0.01
Statistical Significance
p<0.01
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