At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Radiation Therapy (radiation), AZD1390 (drug), Radiation Therapy (radiation), Radiation Therapy (radiation)
- How long the study runs
- Study runs about 101 months (dates as stated)
- About the drug or intervention
- Radiation Therapy — radiation: 35 Gy of Intensity-modulated radiation therapy (IMRT) administered at daily fractions of 3.5 Gy over 10 fractions (2 weeks) · AZD1390 — drug: AZD1390 Administered in 3 Cycles depending on arm: Cycle 0: 1 dose prior to Radiation Therapy. · Radiation Therapy — radiation: 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 — radiation: 60 Gy of intensity- modulated radiation therapy (IMRT) administered at daily fractions of 2 Gy over 30 fractions (6 weeks) · AZD1390 — drug: AZD1390 administered in 1 Cycle. · AZD1390 — drug: AZD1390 Administered in 3 Cycles depending on arm: Cycle 0: 1 dose prior to Radiation Therapy.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 130 Years
- Who
- All
- Number of participants
- 159
- Started
- 2018-04-02
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for recurrent glioblastoma multiforme
- • Phase1 - 159 participants
- • This study will test an investigational drug called AZD1390 in combination with radiation therapy for the treatment of brain tumors
Who can take part?
- • Ages 18 Years to 130 Years
- • Diagnosed with recurrent glioblastoma multiforme
Where?
- • Cambridge - Research Site
- • Glasgow - Research Site
- • Leeds - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
More detail
This first time-in patients (FTIP), open-label, multicentre study of AZD1390 will be conducted in the United States, the United Kingdom and Japan. It consists of three treatment arms: Arm A, B, C. The Japan dose confirmation part (Japan part) is a sub-study of Arm A. Sites from Japan will only participate in the Japan part. This Phase 1 study will assess safety and tolerability of AZD1390 in combination with radiation therapy (RT) in brain malignancies. The combination cohorts have been designed to assess escalating cumulative doses of AZD1390 in settings with 3 different radiation treatment regimens: * Arm A: 35 Gy over 2 weeks with intensity-modulated radiation therapy (IMRT) in patients with recurrent Glioblastoma Multiforme (GBM). Arm A will also include the food effect cohort * Arms B: 30 Gy over two weeks with whole brain radiation therapy (WBRT)/ partial brain radiation therapy (PBRT) in patients with brain metastases. \*\*Arm B has now closed to recruitment\*\* * Arm C: 60 Gy over 6 weeks (IMRT) in patients with primary GBM Each arm provides standard of care RT for the disease setting indicated with the experimental agent being administered in dose escalating cohorts.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 130 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ washout period
- ✓ to assess eligibility for this Arm
What the study is looking for
- ✓Provision of formalin-fixed paraffin embedded tissue sample from primary or that has spread disease
- ✓Karnofsky Performance Score of ≥60.
- ✓Additional Inclusion Criteria Specific for Arm A and Japan:
- ✓Histologically proven diagnosis of GBM. Patients who have had RT for low-grade glioma (LGG) or grade 3 glioma and...
- ✓A radiological diagnosis of recurrent/relapsed or progressive disease according to RANO criteria.
Who cannot take part
- ✗History of severe brain-injury or stroke.
- ✗Patient not eligible for sequential MRI evaluations are not eligible for this study.
- ✗History of epileptic disorder or any seizure history unrelated to tumor
- ✗Treatment with Strong inhibitors or inducers of CYP3A4 within 2 weeks prior to receiving the study treatment
- ✗Concurrent therapy with other seizurogenic medications.
See the full criteria
Where Is This Study? (3 UK sites)
Research Site
Cambridge CB2 0QQ, United Kingdom
Research Site
Glasgow G12 0YN, United Kingdom
Research Site
Leeds LS9 7TF, United Kingdom
