61 The multikinase inhibitor sorafenib has also been investigated in combination with bevacizumab in a series of two phase 1 trials.
75 references were identified eight were clinical trials five phase I studies, one phase II trial, and two phase III trials.
Conversely, we chose to avoid strategies based on adding a consolidation or a maintenance therapy since two phase III trials had been terminated early on the evidence of futility of treatments and an increase of toxicities.
25– 27 However, a pooled analysis of two phase III trials with an identical noninferiority design using MEC demonstrated that palonosetron also induces a statistically significant improvement in the CR rates during the acute phase compared with pooled data from patients who received older 5-HT3RAs.
We have previously reported the results of a combined analysis of two phase II trials of carboplatin and pemetrexed as first-line therapy in 178 MPM patients (Ceresoli et al, 2008): in that study, pooled data of the two trials were retrospectively analysed for comparison between age groups.
This study investigated the HRQoL of patients with haemophilia A treated prophylactically with a new recombinant factor VIII. Two phase 3 trials investigated turoctocog alfa in patients with severe haemophilia A: one in children, one in adults and adolescents.
Harbeck, N, Gascon, P, Jones, CM, Nixon, A, Krendyukov, A, Nakov, R, Li, Y, and Blackwell, K. "Proposed biosimilar pegfilgrastim LA-EP20066) compared with reference pegfilgrastim in Asian patients with breast cancer: an exploratory comparison from two Phase III trials". Future Oncology (London, England) 13, no.
It appears to show that CETP inhibition does not test the HDL hypothesis as originally hoped, and raises a pressing ethical issue regarding two Phase 3 trials of inhibitors, involving more than forty thousand subjects, which are currently in progress.
The feasibility of administering ixabepilone with an anthracycline was shown in two phase I trials.
In two phase III trials a lower response rate (7 11%) was reported (Fossella et al, 2000; Shepherd et al, 2000).
Generally, the FDA requires two phase 3 trials to provide a regulatory approval.
