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

Summary

This study will test an investigational drug called AZD1390 in combination with radiation therapy for the treatment of brain tumors. This is the first time AZD1390 is being given to patients. This study will test safety, tolerability and PK (how the drug is absorbed, distributed and eliminated) of ascending doses of AZD1390 in combination with distinct regimens of radiation therapy

Conditions

• Recurrent Glioblastoma Multiforme
• Primary Glioblastoma Multiforme
• Brain Neoplasms, Malignant
• Leptomeningeal 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.

Sponsors & Collaborators

• AstraZeneca

  lead INDUSTRY

Principal Investigators

• Patrick Wen · Dana-Farber Cancer Institute

• Brandon Imber · Memorial Sloan Kettering Cancer Center

• Mariza Daras · VCU Massey Cancer Center

• Jan Drappatz · UPMC Hospital Radiation Oncology

• Deborah Forst · Massachusetts General Hospital

• Anthony Chalmers · Beatson West of Scotland Cancer Centre

• Rajesh Jena · Cambridge University Hospitals NHS Foundation Trust

• Louise Murray · University of Leeds

• Yoshitaka Narita · National Cancer Center Hospital

• Yoshiki Arakawa · Kyoto University Hospital

• Kazuhiko Mishima · Saitama Medical University International Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

130 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-02

Primary Completion

2026-09-16

Completion

2026-09-16

FDA Drug

Yes

Countries

• United States
• Japan
• United Kingdom

Study Locations