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Although designed as a phase I trial, this study also showed considerable post-treatment variation in tumour volume, from 54% reduction to 28% increase, with a mean change of 26% reduction.
For the purpose of a dose-seeking phase I trial, this sequence offers very appealing guidance for the increment set up; because the absolute doses and the absolute dose change grow larger and larger with constant incremental ratios (≈1.61; ≈+61%) [ 1, 4, 5].
In an ongoing randomized, controlled, phase II/III trial, this vaccine was shown to be efficacious, immunogenic and to have a clinically acceptable safety profile in more than 6000 Chinese women aged 18 25 y.
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Neutropenia was the major toxicity reported with docetaxel in Phase I trials; this was dose- but not schedule-dependent (Cortes and Pazdur, 1995).
In this phase I trial, the schedule of capecitabine was designed to simulate infusional 5FU to maximise radiosensitisation and cytotoxicity.
Dr. Robert Watkins IV, an orthopedic spine surgeon and co-director of the Marina Spine Center at Marina Del Rey Hospital, said even the start of a Phase I trial in this area of medicine is encouraging.
A first phase I trial addressing this issue has been completed in relapsed ovarian cancer patients (http://www.clinicaltrials.gov NCT00382733).
AMP-224 is a recombinant B7-DC-Fc fusion protein, and a phase I trial of this agent is also underway.
In a phase I trial of this combination chemotherapy, the response rate of patients without prior chemotherapy was also reported to be 45% (Seto et al, 2002).
In phase I/II trial of this study, patients with attempted surgical resection were selected while those with R0 or R1 resections were excluded as there are well-known standard therapies available.
ON 01910.Na (rigosertib), which has been claimed to interact with the Plk pathway, has also shown clinical efficacy in pancreatic cancer (Ma et al, 2011) and is currently recruiting a phase II/III trial in this indication.
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