EUCTR2016-003468-38-FR
Active, Not Recruiting
Phase 1
Phase I/IIa study of concomitant radiotherapy with olaparib and temozolomide in unresectable high grade gliomas patients - OLA-TMZ-RTE-01
Centre François baclesse0 sitesMarch 30, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Centre François baclesse
- Status
- Active, Not Recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For inclusion in the study subjects should fulfill the following criteria:
- •Provision of signed informed consent prior to any study specific procedures
- •Histologically\-confirmed diagnosis of glioblastoma (IDH\-wildtype, IDH\-mutant or NOS, except gliosarcoma), non resectable or partially resectable with a residual tumor on pre\-radiotherapy MRI. The presence of a residual disease will be assessed by the radiologist on the pre\-radiotherapy imaging as compared with initial imaging. • IMRT must start within 6 weeks after histological diagnosis
- •Age between 18 and 70 years ;
- •Adequate bone marrow and organ function measured within 15 days prior to administration of study treatment as defined below:
- •\- Haemoglobin \= 10\.0 g/dL with no blood transfusions (packed red blood cells and platelet transfusions) in the past 28 days before start of treatment
- •\- Absolute neutrophil count (ANC) \= 1\.5 x 109/L
- •o No features suggestive of MDS/AML on peripheral blood smear
- •\- Platelet count \= 100 x 109/L
- •\- White blood cells (WBC) \> 3x109/L
Exclusion Criteria
- •Patients should not enter the study if any of the following exclusion criteria are fulfilled
- •Any prior radiotherapy to brain
- •Any prior chemotherapy or immunotherapy
- •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •Candidate for a concomitant therapy with Tumor\-Treating Fields during the maintenance treatment
- •Previous enrolment in the present study
- •Participation in another clinical trial protocol within 30 days prior to enrolment;
- •Any previous treatment with a PARP inhibitor, including olaparib.
- •Patients with second primary cancer, except: adequately treated non\-melanoma skin cancer, curatively treated in\-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \= 5 years
- •Gadolinium hypersensitivity, or any contraindication to undergo MRI examination (Pacemaker, brain aneurysms clips)
Outcomes
Primary Outcomes
Not specified
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