180
Participants
Start Date
April 2, 2018
Primary Completion Date
September 16, 2026
Study Completion Date
September 16, 2026
Radiation Therapy
35 Gy of Intensity-modulated radiation therapy (IMRT) administered at daily fractions of 3.5 Gy over 10 fractions (2 weeks)
AZD1390
"AZD1390 Administered in 3 Cycles depending on arm:~Cycle 0: 1 dose prior to Radiation Therapy. Cycle 1: 2 weeks Intermittent or continuous dosing during Radiation Therapy. Cycle 2: 2 weeks adjuvant treatment after Radiation Therapy. For optional food effect assessment in Arm A, 2 doses prior to RT under both fed and fasted conditions. Note: the food effect assessment is currently open to recruitment.~Arm A includes the Japan part following the same dosing administration."
Radiation Therapy
30 Gy of whole brain radiation therapy (WBRT) or partial brain radiation therapy (PBRT) administered at daily fractions of 3 Gy over 10 fractions (2 weeks).
Radiation Therapy
60 Gy of intensity- modulated radiation therapy (IMRT) administered at daily fractions of 2 Gy over 30 fractions (6 weeks)
AZD1390
AZD1390 administered in 1 Cycle. AZD1390 administration concomitantly with RT (2 weeks). Cycle 1 also contains an additional 5 days (post completion of RT with AZD1390 administration). Arm is Closed.
AZD1390
"AZD1390 Administered in 3 Cycles depending on arm:~Cycle 0: 1 dose prior to Radiation Therapy. Cycle 1: 6 weeks Intermittent or continuous dosing during Radiation Therapy. Cycle 2: 2 weeks adjuvant treatment after Radiation Therapy. Arm is closed."
RECRUITING
Research Site, New York
RECRUITING
Research Site, Pittsburgh
RECRUITING
Research Site, Richmond
RECRUITING
Research Site, Boston
RECRUITING
Research Site, Boston
RECRUITING
Research Site, Chūōku
RECRUITING
Research Site, Hidaka-shi
RECRUITING
Research Site, Kyoto
ACTIVE_NOT_RECRUITING
Research Site, Cambridge
COMPLETED
Research Site, Glasgow
RECRUITING
Research Site, Leeds
WITHDRAWN
Research Site, London
Lead Sponsor
AstraZeneca
INDUSTRY