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COMMENTARY

Objective Data Rather Than Opinion in the Interpretation of the Legitimate Goals of Phase 1 Oncology Trials

Pages 11-12 | Published online: 11 Jun 2009

REFERENCES

  • Code of Federal Regulations, Title 21,312.21 “Phase of an investigation,” April, 1, 2004
  • Bookman M. A., McGuire W. P., Kilpatrick D., et al. Carboplatin and paclitaxel in ovarian carcinoma: A phase I study of the Gynecologic Oncology Group. J. Clin. Oncol. 1996; 14(6)1895–1902
  • Horstmann E., McCabe M. S., Grochow L., et al. Risks and benefits of phase 1 oncology trials, 1991–2002. N. Engl. J. Med. 2005; 352(9)895–904
  • Higby D. J., Wallace H. J., Albert D. J., et al. Diaminodichloroplatinum: A phase I study showing responses in testicular and other tumors. Cancer 1974; 33: 1219–1225
  • Drucker B. J., Talpaz M., Resta D. J., et al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N. Engl. J. Med. 2001; 344(14)1031–1037

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