A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

April 2, 2018

Primary Completion Date

September 16, 2026

Study Completion Date

September 16, 2026

Conditions
Recurrent Glioblastoma MultiformePrimary Glioblastoma MultiformeBrain Neoplasms, MalignantLeptomeningeal Disease (LMD)
Interventions
RADIATION

Radiation Therapy

35 Gy of Intensity-modulated radiation therapy (IMRT) administered at daily fractions of 3.5 Gy over 10 fractions (2 weeks)

DRUG

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

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

Radiation Therapy

60 Gy of intensity- modulated radiation therapy (IMRT) administered at daily fractions of 2 Gy over 30 fractions (6 weeks)

DRUG

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.

DRUG

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."

Trial Locations (12)

10065

RECRUITING

Research Site, New York

15232

RECRUITING

Research Site, Pittsburgh

23298

RECRUITING

Research Site, Richmond

02114

RECRUITING

Research Site, Boston

02215

RECRUITING

Research Site, Boston

104-0045

RECRUITING

Research Site, Chūōku

350-1298

RECRUITING

Research Site, Hidaka-shi

606-8507

RECRUITING

Research Site, Kyoto

CB2 0QQ

ACTIVE_NOT_RECRUITING

Research Site, Cambridge

G12 0YN

COMPLETED

Research Site, Glasgow

LS9 7TF

RECRUITING

Research Site, Leeds

W1T 7HA

WITHDRAWN

Research Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY