Recurrent Glioblastoma Multiforme Clinical Trial
Official title:
A Phase I, Multicentre 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.
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
This first time-in patients (FTIP), open-label, multicentre study of AZD1390 will be conducted in the United States and in the United Kingdom, and it consists of three treatment arms: Arm A, B, C. 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) - 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00597493 -
Ph. 2 Sorafenib + Protracted Temozolomide in Recurrent GBM
|
Phase 2 | |
| Completed |
NCT00379470 -
Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM)
|
Phase 3 | |
| Recruiting |
NCT01737346 -
Procarbazine and Lomustine in Recurrent Glioblastoma
|
Phase 2 | |
| Active, not recruiting |
NCT01464177 -
Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme
|
Phase 2 | |
| Active, not recruiting |
NCT00562419 -
CT-322 in Treating Patients With Recurrent Glioblastoma Multiforme and Combination Therapy With Irinotecan
|
Phase 2 | |
| Completed |
NCT00071539 -
Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT02062827 -
Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma
|
Phase 1 | |
| Completed |
NCT00509301 -
Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme
|
Phase 1 | |
| Recruiting |
NCT05868083 -
The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the Recurrent Glioblastoma
|
Phase 1 | |
| Completed |
NCT01576666 -
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01738646 -
Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients
|
Phase 2 | |
| Completed |
NCT00306618 -
Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma
|
Phase 2 | |
| Completed |
NCT01934361 -
Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme
|
Phase 1 | |
| Terminated |
NCT04915404 -
Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV)
|
Phase 1/Phase 2 | |
| Terminated |
NCT01756729 -
Post-approval Study of NovoTTF-100A in Recurrent GBM Patients
|
Phase 4 | |
| Completed |
NCT00747253 -
Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors
|
Phase 1 | |
| Completed |
NCT00883298 -
Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme
|
Phase 2 | |
| Completed |
NCT00481455 -
Phase 2 Study of Panzem Nanocrystal Colloidal Dispersion (NCD) in Combination With Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme (GBM)
|
Phase 2 | |
| Recruiting |
NCT04689087 -
A Prospective, Open-label, Single-arm Clinical Study
|
N/A |