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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Recurrent Glioblastoma, Brain Tumor

Thank you

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 SiteBeverly, Massachusetts