It is an extension study for patients who have participated in one of the qualifying development program studies with mavrilimumab and, at present, is recruiting participants.
In the absence of treatment-related toxicity, patients were offered to continue their treatment at 1.0 mg per day during an extension study for another 11 months.
However, one compound, the PI3 Kinase δ selective inhibitor CAL-101 is currently being tested in a phase 1 clinical trial with an extension study for patients with AML (Table 1) [ 25].
This study was an extension study for patients successfully completing a previous equivalence study, which was a randomised, double blind study to test the clinical equivalence of IR and CR formulations of hydromorphone and morphine in 200 adult patients with chronic moderate-to-severe cancer pain [ 34].
Participants underwent phlebotomy and stool submission at preentry and entry visits, at weeks 7 and 8 while receiving SBI, at week 12 after a 4-week washout, and then again at the end of 48 weeks for those participants who entered an extension study.
The patients were to receive treatment with tasquinimod for 28 days, followed by a 1-week off period, and during an extension study thereafter for up to 12 months.
43 HbA1c reductions were sustained for up to 2 years in an extension study conducted with dapagliflozin as add-on to metformin.
There are publications available for an extension of study CS21, which reports on outcomes with longer follow-up.
Of the enrolled patients, 51 patients (MPH-LA, n = 38; placebo, n = 13) had discontinued in the maintenance of effect phase of the core study prior to the implementation of an amendment to the inclusion criteria for the extension study protocol (treatment non-responders were required to fulfil both the lack of therapeutic effect criteria).
