NCT00503204CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Assess the safety and tolerability of cediranib in combination with oral lomustine and to confirm a dose for further studies with this combination.
Study Overview
Brief Summary
This is a Phase I, open-label, multi-centre study designed to assess the safety and tolerability of Cediranib in combination with lomustine in patients with primary recurrent malignant brain tumour.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
Lomustine + Cediranib (AZD2171)
Intervention: Cediranib (Drug)
1
Experimental
Lomustine + Cediranib (AZD2171)
Intervention: Lomustine (Drug)
Outcomes
Primary Outcomes
Assess the safety and tolerability of cediranib in combination with oral lomustine and to confirm a dose for further studies with this combination.
Time Frame: Assessed at each visit
Secondary Outcomes
- Compare the pharmacokinetics of cediranib alone versus when in combination with lomustine as measured by minimum steady state plasma concentration (Css,min) steady-state plasma concentration(assessed 2 & 4 hours post dosing)
Investigators
Study Sites (1)
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