Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrent Glioblastoma; Brain Tumor
Intervention: Cediranib (Drug); Lomustine (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Nick Botwood, BSc, MBBS, MRCP, MFPM, Study Director, Affiliation: AstraZeneca
Tracy Batchelor, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
Overall contact:
AstraZeneca Cancer Support, Network, Phone: 1-866-992-9276, Email: EnquiriesMailbox.AZD2171Trials@target.azemw.net
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.
Clinical Details
Official title: 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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Assess the safety and tolerability of cediranib in combination with oral lomustine and to confirm a dose for further studies with this combination.
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
AstraZeneca Cancer Support, Network, Phone: 1-866-992-9276, Email: EnquiriesMailbox.AZD2171Trials@target.azemw.net
Research Site, Sutton, United Kingdom; Recruiting
Research Site, Boston, Massachusetts, United States; Recruiting
Additional Information
Starting date: September 2007
Ending date: December 2008
Last updated: February 13, 2008
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