In a subsequent phase I/II clinical trial of this combination, 54 patients with AML or high-risk MDS, either relapsed or unsuitable for first-line chemotherapy, received a fixed dose of decitabine and escalating doses of VPA.
Based on these phase 1 data, a daily dose of 10 mg of everolimus was used in a subsequent phase 2 study in patients with mRCC [ 12], and in the pivotal phase 3 RECORD-1 trial [ 13, 14].
It was the intention to use the CRT regimen at the MTD in a subsequent phase II trial in an expanded number of patients (100).
In a subsequent phase 2 study in previously treated patients with HCC and Child-Pugh A cirrhosis, the tivantinib dose was reduced to 240 mg BID and a modified dose-reduction schema was implemented because of grade 3 or greater neutropaenia (Santoro et al, 2012).
In a subsequent Phase 1 trial in which the same mPEG-uricase was administered intravenously to subjects with refractory chronic gout, antibodies to PEG-uricase, described as "mostly IgG2 and specific for PEG", developed in 9 of 24 patients, in some of whom the enzyme was cleared rapidly without evidence of allergic reactions.
Based on the tolerability established in a subsequent phase II study in breast cancer, the doses of dalotuzumab 10 mg kg 1 per week and ridaforolimus 20 mg daily (5 days on/2 day off) were recommended for further evaluation (Ebbinghaus et al, 2011).
The first inpatient study for OKZ was tailored to play a bridging role between the first-in-human and a subsequent phase IIb study in moderate-to-severe RA.
A subsequent phase Ib trial in semi-immune adult volunteers, living in an area of Burkina Faso where malaria transmission is seasonally hyperendemic, found the vaccine to be safe at a dose of 30 µg, with less local reactogenicity in P. falciparum exposed individuals than was observed after the second and third doses in naïve volunteers [7].
29 In line with this simulation, a subsequent phase III trial in renal cell carcinoma showed that progression-free survival and overall survival (OS) were significantly improved (P < 0.001) with daily 10 mg dosing.
Another effect of the use of air-entraining agent was revealed in a subsequent phase of the experiment in a significant water absorption.
