A Phase I, Open Label, Multi-Centre Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Lomustine Chemotherapy for Patients With Primary Recurrent Malignant Brain Tumours for Whom Lomustine Would be a Standard Therapy
18 Years
N/A
Both
Recurrent Glioblastoma, Brain Tumor
Trial Information
A Phase I, Open Label, Multi-Centre Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Lomustine Chemotherapy for Patients With Primary Recurrent Malignant Brain Tumours for Whom Lomustine Would be a Standard Therapy
Inclusion Criteria:
- Primary recurrent malignant brain tumour for whom lomustine would be standard therapy
- diagnosis & stage
- Patients received no more than 2 previous systemic chemotherapy regimes
- Life Expectancy > 12 weeks
- Patients must be at least 3 months from the completion of cranial radiation therapy
Exclusion Criteria:
- History of poorly controlled high blood pressure
- Recent major surgery prior to entry into the study
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Assess the safety and tolerability of cediranib in combination with oral lomustine and to confirm a dose for further studies with this combination.
Outcome Time Frame:
Assessed at each visit
Safety Issue:
No
Principal Investigator
Jane Robertson
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D8480C00057
NCT ID:
NCT00503204
Start Date:
September 2007
Completion Date:
December 2008
Related Keywords:
- Recurrent Glioblastoma
- Brain Tumor
- cancer
- tumor
- advance solid tumour
- glioblastoma
- malignant brain tumour
- Brain Neoplasms
- Glioblastoma
Name | Location |
|---|---|
| Research Site | Beverly, Massachusetts |
