At a glance
ClinicalIndex Comparison Record- ✓Provision of formalin-fixed paraffin embedded tissue sample from primary or metastatic disease
- ✓Karnofsky Performance Score of ≥60
- ✓Histologically proven diagnosis of GBM (Arm A)
- ✓Radiological diagnosis of recurrent/relapsed or progressive disease according to RANO criteria (Arm A)
- ✕Chemotherapy or investigational drug within 28 days; CCNU/BCNU within 6 weeks prior to first dose (Arms A/C)
- ✕Checkpoint inhibitors within 28 days; other agents within 7 days of beginning study treatment (Arm B)
- ✕History of severe brain-injury or stroke
- ✕Not eligible for sequential MRI evaluations
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of AZD1390 in Combination With Radiation Therapy in Patients With Glioblastoma Multiforme and Brain Metastases From Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Radiation Therapy and AZD1390 for Recurrent Glioblastoma Multiforme and 3 related conditions. Currently recruiting, targeting 180 participants across 12 sites in 3 countries.
Detailed 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
Study Details
Timeline
Interventions
35 Gy of Intensity-modulated radiation therapy (IMRT) administered at daily fractions of 3.5 Gy over 10 fractions (2 weeks)
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.
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).
60 Gy of intensity- modulated radiation therapy (IMRT) administered at daily fractions of 2 Gy over 30 fractions (6 weeks)
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 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.