Other potential limitations include the use of an enriched sample of patients who had demonstrated tolerability and responsivity to lurasidone during up to 7.5 months of initial lurasidone therapy, and reliance on relatively minimal efficacy measures.
Moreover, etanercept (a hybrid molecule consisting of TNFRII linked to the Fc domain of human IgG1) administration in nine subjects with IPF demonstrated tolerability, with functional improvement in some [75].
In a phase I dose-escalation study, regorafenib demonstrated tolerability and antitumour activity in solid tumour patients.
The immunogenicity of GPC-3 has been well demonstrated, and a phase I clinical cancer vaccine trial has already demonstrated tolerability and biologic efficacy (Sawada et al, 2012).
Assessment in several other tumor models demonstrated tolerability with OXY at 300 mg/kg given once daily or 200 mg/kg given twice daily.
In CML, combining two active agents, peginterferon-alfa-2a (Pegasys®) and IM, demonstrated tolerability and improved efficacy over IM-monotherapy [ 45], but the immunological implications of IFN-α was not addressed.
SIR-Spheres® (Sirtex Medical Limited, North Sydney, Australia), that contain the β-emitter yttrium-90, have EU approval for use in inoperable liver cancer and have been utilised in published phase I-II studies [ 9- 11], which have demonstrated tolerability, high response rates and improved time to progression versus chemotherapy alone.
Laboratory-based evaluation of candidate medications in animals and humans is a valuable means to demonstrate safety, tolerability and initial efficacy of potential medications.
A prospective, multicenter study, Albumin in Subarachnoid Haemorrhage (ALISAH), designed to demonstrate the tolerability and safety of four doses of albumin is currently in progress [93].
Results demonstrate safety, tolerability (particularly at the lower doses tested) and immunogenicity of the formulation.
