Pharmacokinetic analysis of RO4929097 showed similar Cmax and AUCt as phase I monotherapy study (Tolcher et al, 2012).
The results from the pooled analysis of the monotherapy study, as well as the initial combination and add-on studies, concluded that saxagliptin had a low risk of hypoglycemia when used as monotherapy or in combination with metformin, SUs, or TZDs.
While patritumab had been previously studied in a phase 1 study as a monotherapy in patients with solid tumors refractory to prior treatments (LoRusso et al., 2013), a predictive biomarker for response to patritumab had not yet been identified before initiation of the phase 2 study.
These trials are ongoing, as are phase II monotherapy studies of first- and second-line treatment in patients with NSCLC in which ZD0473 is being given at a dosage of 120 150 mg m−2 every 3 weeks.
Cetuximab is being studied as a monotherapy and in combination with radiotherapy and/or chemotherapy in several clinical studies.
Recently the cSRC inhibitors Dasatinib and Bosutinib were studied as a monotherapy in humans, but showed no clear reduction of antitumor activity, indicating that before further studies are done, clear biomarkers should be found for proper patient selection [ 54].
Ofatumumab has also been studied as a monotherapy in FL.
Although Reolysin has significant anticancer activity when administered as a monotherapy, several preclinical and clinical studies suggest that it may be best utilized in combination with standard chemotherapy.
Vandetanib was evaluated as a monotherapy in two of the studies: in ZEPHYR (NCT00404924), patients received vandetanib 300 mg/day (n = 617) or placebo (n = 307); and in ZEST (NCT00364351), patients received vandetanib 300 mg/day (n = 623) or erlotinib 150 mg/day (n = 617).
In phase I and II clinical studies, sagopilone (as a monotherapy or in combination with carboplatin or cisplatin) was well tolerated and demonstrated clinical benefit in several solid tumour types (Rustin et al, 2007; Gauler et al, 2008; McMeekin et al, 2008; Wenk et al, 2008; Schmid et al, 2010).
