Phase I trials with

Trump DL, Egorin M, Ramanathan R, et al. A novel oral taxane (BMS-275183) a phase I trial with evaluation of pharmacokinetics, pharmacodynamics and bioavailability. 

Peng B et al (2004) Pharmacokinetics and pharmacodynamics of imatinib in a phase I trial with chronic myeloid leukemia patients. J Clin Oncol 22 935-942... 

Ribas A, Camacho LH, Lopez-Berestein, et al. Antitumor activity in melanoma and anti-self responses in a phase I trial with the anti-cytotoxic T lymphocyte-associated... 

Also, paclitaxel is the most widely used anticancer agent for non-small cell lung cancer [420], Liposomal encapsulated paclitaxel faces the problem of formulation due to the drug s high hydrophobicity. However, a phase I trial with liposomal paclitaxel reported dose-limiting toxicity at the dose of 150 mg/m2/week. Besides, the whole blood clearance of paclitaxel was similar for liposomal and free paclitaxel. 

B. Peng, M. Hayes, D. Resta,A. Racine-Poon, B. J. Druker, M.Talpaz, C. L. Sawyers, M. Rosamilia, J. Ford, P. Lloyd, and R. Capdeville, Pharmacokinetics and pharmacodynamics of imatinib in a Phase I trial with chronic myeloid leukemia patients, J. Clin. Oncol. 22 (2004), 935-942. 

The clinical trials with elliptinium (5) have generally progressed to the phase II stage. However, one phase I trial with 5 was reported in 1985 (277). Twenty-nine patients were treated with 5 (weekly intravenously, 40 mg/m increased to 150... 

Trials of gene therapy in hemophilia A and B, to determine safety and efficacy, are under way (2). Three patients with hemophilia B were treated in a phase I trial with a recombinant adenovirus-associated vector expressing human blood-coagulation factor IX (3). There was no evidence of formation of inhibitory antibodies against factor IX. In a phase I trial with a recombinant adenovirus-associated vector expressing human blood-coagulation factor IX, there was no evidence of germ-line transmission of vector sequences (3). 

Logan TF, Kaplan SS, Bryant JL, Emstoff MS, Krause JR, Kirkwood JM. Granulocytopenia in cancer patients treated in a phase I trial with recombinant human tumor necrosis factor. J Immunother 1991 10(2) 84-95. 

LCL-161 developed by Norvatis [87], Soon after, Tetralogic entered Phase I trials with their bivalent antagonist TL3271 [88] and Genentech began clinical trials with another small molecule antagonist GDC-0917 [89], while Ascenta announced the initiation of Phase I trials with their diazabicycle monomer AT-406 in the spring of 2011 [90]. All of these molecules are believed to be pan-specific so, it will activate the NF-kB pathway as well as promote caspase 9, 3 and 7 activation. 

Unconventional phase I trials with larger cohorts and more rapid dose intervals and dose escalation should be foreseen. 

Braat, H., Rottiers, R, Hommes, D. W., Huyghebaert, N., Remaut, E., Remon, J. R, et al. (2006). A phase I trial with transgenic bacteria expressing interleukin-10 in Crohn s disease. Clinical Gastroenterology and Hepatology, 4, 754—759. 

Observational studies The most frequent grade 3-A adverse events seen in a phase I trial of 28 patients witir relapsed/refractory multiple myeloma treated with elotuzumab and bortezomib were lymphopenia (25%) and fatigue (14%). Two elotuzumab-related serious reactions, chest pain and gastroenteritis, occurred in the same patient [135 ]. In a second similar phase I trial with 35 patients with relapsed/refractory multiple myeloma treated with elotuzumab... 

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