Accelerated titration designs - Biometric Research Branch

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ACCELERATED TITRATION DESIGNS 111
23. G.J. Rustin, S.M. Galbraith, H. Anderson, M. Stratford, L.K. Folkes, L. Sena, L. Gumbrell
and P.M. Price (2003) Phase I clinical tral of weekly combretastatin A4 phosphate: clinical
and pharacokinetic results. J. Clin. Oncology, 21(15), 2815-22.
24. A. Chatterjee, R Digumari, RN. Mamdi, K. Katneni, V.V. Upreti, A. Surath, M.L.
Srinivas, S. Uppalapati, S. Jiwatani, S. Subramanam and N.R Srinivas (2004) Safety,
tolerabilty, pharacokinetics, and pharacodynamics of an orally active novel camptothecIn
analog, DRF-1042, in refractory cancer patients in a phase I dose escalation
study. J. CUn. Pharmacology, 44(7), 723-36.
25. M.A. Vilalona-Calero, S.G. Eckhardt, G. Weiss, M. Hidalgo, J.H. Beijnen, C. van
Kesteren, H. Rosing, E. Campbell, M. Kraynak, L. Lopez-Lazaro, C. Guzman, D.D.
Yon Hoff, J. Jimeno and E.K. Rowinsky (2002) A phase I and pharacokinetic study
of ecteinascidin-743 on a daily x 5 schedule in patients with solid malignancies. Clin.
Cancer Res., 8(1), 75-85.
26. Y.J. Ko, G.J. Bubley, R Weber, C. Redfern, D.P. Gold, L. Finke, A. Kovar, T. Dahl and
S.D. Gilies (2004) Safety, pharacokinetics, and biological pharacodynamics of the
immunocytokine EMD 273066 (huKS-IL2): results of a phase I tral in patients with
prostate cancer. 1. Immunotherapy, 27(3), 232-9.
27. S. Goel, K. Desai, A. Bulgar, A. Fields, G. Goldberg, S. Agrawal, R Marin, M. Grndel
and S. Mani (2003) A safety study of a mixed-backbone oligonucleotide (GEM231) targeting
the type I regulatory subunit alpha of protein kinase A using a continuous infusion
schedule in patients with refractory solid tumors. CUn. Cancer Res., 9(11), 4069-76.
28. H.X. Chen, J.L. Marshall, E. Ness, RR Marin, B. Dvorchik, N. Rizvi, J. Marquis, M.
McKinlay, W. Dahut and M.J. Hawkins (2000) A safety and pharacokinetic study of
a mixed-backbone oligonucleotide (GEM231) targeting the type I protein kinase A by
two-hour infusions in patients with refractory solid tumors. CUn. Cancer Res., 6(4), 1259-
66.
29. P. Borchmann, R Schnell, L Fuss, O. Manzke, T. Davis, L.D. Lewis, D. Behnke, C. Wickenhauser,
P. Schiler, V. Diehl and A. Engert (2002) Phase I tral of the novel bispecific
molecule H22 x Ki-4 in patients with refractory Hodgkin lymphoma. Blood, 100(9),
3101-7.
30. S.M. Gadgeel, R.R Boinpally, L.K. Heilbrun, A. Wozniak, V. Jain, B. Redman, M. Zalupski,
R Wiegand, R Parchment and P.M. LoRusso (2003) A phase I clinical tral of spicamycin
derivative KR5500 (NSC 650426) using a phase I accelerated titration '2B'
design. Investigational New Drugs, 21(1), 63-74.
31. N.E. Schoemaker, C. van Kesteren, H. Rosing, S. Jansen, M. Swar, J. Lieverst, D. Fraier,
M. Breda, C. Pellzzoni, R Spinell, M. Grazia Porro, J.H. Beijnen, J.H. Schellens and
W.W. ten Bokkel Huinink (2002) A phase I and pharacokinetic study of MAG-CPT, a
water-soluble polymer conjugate of camptothecin. Br. 1. Cancer, 87(6),608-14.
32. Y. Matsumura, M. Gotoh, K. Muro, Y. Yamada, K. Shirao, Y. Shimada, M. Okuwa,
S. Matsumoto, Y. Miyata, H. Ohkura, K. Chin, S. Baba, T. Yamao, A. Kannam, Y.
Takamatsu, K. Ito and K. Takahashi (2004) Phase I and pharacokinetic study of
MCC-465, a doxorubicin (DXR) encapsulated in PEG iinunoliposome, in patients with
metastatic stomach cancer. Ann. Oncology, 15(3),517-25.
33. S. Clive, D.J. Webb, A. MacLellan, A. Young, B. Byrne, L. Robson, J.E Smyth and D.L
Jodrell (2001) Forear blood flow and local responses to peptide vasodilators: a novel
pharacodynamc measure in the phase I tral of antagonist G, a neuropeptide growth
factor antagonist. CUn. Cancer Res., 7(10), 3071-8.