Once the recommended Phase II dose
has been identified, the second part of the study will evaluate the safety and tolerability of birinapant in combination with KEYTRUDA in several cohorts.
The interim safety results of the 27 patients with available safety assessments showed that there was no dose limiting toxicity for the 10 patients enrolled at the 160 mg dose thus the Phase II portion of the trial is being conducted at the recommended Phase II dose
of 160 mg of neratinib per day.
The study will determine the maximum tolerated dose and recommended Phase II dose
Currently, the company's ongoing, open-label Phase I/II study is enrolling patients and is designed to evaluate the safety of onapristone in the selected patient population, determine the recommended Phase II dose
and assess the potential benefits of single-agent onapristone and the combination of onapristone with abiraterone.
The patients will receive anti-Notch1 at the recommended Phase II dose
of 1.5mg/kg every three weeks.
It was observed that the higher 30mg dose had a stronger immune response, and this was chosen to be the recommended Phase II dose
(RPTD) for the ongoing randomised phase of 226 patients.
The open label trial is to enrol patients with relapsed or refractory acute myeloid leukaemia in a first dose escalation phase for safety evaluation, and the expansion group phase for determination of the recommended Phase II dose
. The company aims to report preliminary results from the trial in 2016.
The study intends to determine the recommended Phase II dose
and evaluate the safety and preliminary evidence of anti-cancer activity in Asian patients.
The Phase I trial will assess onapristone in sustained release and immediate release formulations in about six dose levels (10-50mg BID and 100mg QD) in order to identify the recommended Phase II dose
and determine the overall safety profile of the drug.
As previously reported, the recommended Phase II dose
of saridegib in combination with gemcitabine was set at 160 mg administered orally once daily, which is the same as the single agent Phase II dose of saridegib.
The maximum tolerated dose (MTD) and the recommended Phase II dose
for ARRY-520 was 1.50 mg/m2/ a day with granulocyte-colony stimulating factor (G-CSF).