A Modular Phase I/IIa, Open-Label, Multicentre Study to Assess AZD2014 in Combination with Novel Anti-Cancer Agents in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma (INHIBITOR study)
Core: Relapsed or Refractory Diffuse Large B-Cell Lymphoma
18 Years - 130 Years
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Sept 2016 by AstraZeneca
No locations available
|Experimental: AZD2014 plus Ibrutinib Combination|
AZD2014 and ibrutinib will be dosed together in the morning under fasting conditions. When possible, the morning doses of AZD2014 and ibrutinib should be taken at approximately the same time each day. The morning doses must be taken in a fasted state (water to drink only) from at least 2 hours prior to the dose to at least 1 hour post dose. AZD2014 will be taken orally twice per day on an intermittent dosing schedule, 2 days on and 5 days off of each week. On days of AZD2014 dosing, ibrutinib will be taken with the morning dose of AZD2014.
AZD2014 will be supplied as oral tablets. AZD2014 will be taken orally twice per day on an intermittent dosing schedule, 2 days on and 5 days off of each week.
Other Name: Vistusertib
Ibrutinib will be provided in hard gelatin capsules in opaque high-density polyethylene bottles. On days of AZD2014 dosing, ibrutinib will be taken with the morning dose of AZD2014.
Other Name: IMBRUVICA®