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Pratt CB, Sinkule JA, Etcubanas E, et al. Phase I clinical and pharmacokinetic study of bisantrene in refractory pediatric solid tumors. Invest New Drugs. 1986;4(2):149-53doi: 10.1007/BF00194594.
Pratt, C. B., Sinkule, J. A., Etcubanas, E., Douglass, E. C., Crom, D. B., Choi, K., & Avery, L. (1986). Phase I clinical and pharmacokinetic study of bisantrene in refractory pediatric solid tumors. Investigational new drugs, 4(2), 149-53. https://doi.org/10.1007/BF00194594
Pratt, C B, et al. "Phase I clinical and pharmacokinetic study of bisantrene in refractory pediatric solid tumors." Investigational new drugs vol. 4,2 (1986): 149-53. doi: https://doi.org/10.1007/BF00194594
Pratt CB, Sinkule JA, Etcubanas E, Douglass EC, Crom DB, Choi K, Avery L. Phase I clinical and pharmacokinetic study of bisantrene in refractory pediatric solid tumors. Invest New Drugs. 1986;4(2):149-53. doi: 10.1007/BF00194594. PMID: 3733375.
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Invest New Drugs. 1986;4(2):149-53. doi: 10.1007/BF00194594.

Phase I clinical and pharmacokinetic study of bisantrene in refractory pediatric solid tumors.

Investigational new drugs

C B Pratt, J A Sinkule, E Etcubanas, E C Douglass, D B Crom, K Choi, L Avery

PMID: 3733375 DOI: 10.1007/BF00194594

Abstract

Fourteen patients with pediatric malignant solid tumors, median age 15 years, received 22 courses of bisantrene in a Phase I study. Dosage escalations ranged from 10 to 120 mg/m2 daily for 5 consecutive days. Toxicity included myelosuppression and phlebitis. A sensitive (detection limit of 2 ng/ml) and specific HPLC method was developed to quantitate bisantrene in patient's plasma and urine. Peak plasma concentrations at the end of 60 minute infusions ranged from 568 ng/ml at 10 mg/m2 to 6800 ng/ml at the 100 mg/m2 dosage. The elimination half life (T 1/2 beta) averaged about 10 hours but increased to 20 hours in a patient with liver disease. Only 2.4 - 10% of the bisantrene dose was eliminated in the urine suggesting that the liver may be the major route of elimination for this antineoplastic anthracene derivative.

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References

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