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Both WT-HH and WT-LL mice showed an initial escalation in drinking (time effect: F[6,78] = 27.1, p < 0.001; week 7 v. week 1: WT-HH and WT-LL p < 0.001).
Following an initial escalation strategy mimicking the standard design, we have the following observations on nine patients; level 1: 0 toxicities/three patients level 2: 0 toxicities/three patients level 3: 2 toxicities and one non-toxicity/three patients.
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It is common to see DEC involving several hundred patients, building on an initial dose escalation study that may have no > 20 to 30 patients.
Thirty-six of 37 patients received an initial dose escalation dose of 40 mg of octreotide LAR (97%).
The study consisted of an initial dose-escalation cohort, and a second expansion cohort of patients treated at MTD with additional correlative PK and PD studies.
An initial dose-escalation study was performed to determine the optimal dose of rapamycin in FaDu xenograft-bearing BALB/c mice.
Preliminary data from an initial phase I dose escalation trial have been encouraging, indicating that dasatinib is generally well tolerated and produces hematologic and cytogenetic responses in patients with imatinib-resistant CML in all phases of the disease.
53, 54 In 2006, an initial Phase I dose-escalation study of monotherapy with tivantinib was completed in 74 patients with metastatic solid tumors.
Six patients were entered at 2.0 mg/kg as an initial expansion cohort before further escalation, and six were entered at 3.5 mg/kg as a confirmatory expanded cohort of the highest planned dose after protocol revision.
This dose escalation study evaluated the effects in an initial set of 27 patients, followed by a cohort of 12 patients with metastatic melanoma.
Cohorts of three to six men were treated with an initial oral dose of 30 mg/day and subsequent dose escalation.
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