Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00503204
First received: July 16, 2007
Last updated: November 24, 2009
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Glioblastoma Brain Tumor |
Drug: Cediranib Drug: Lomustine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Time Frame: assessed 2 & 4 hours post dosing ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Lomustine + Cediranib (AZD2171)
|
Drug: Cediranib
oral tablet
Other Names:
Drug: Lomustine
oral capsule
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503204
Locations
| United States, Massachusetts | |
| Research Site | |
| Boston, Massachusetts, United States | |
| United Kingdom | |
| Research Site | |
| Sutton, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Jane Robertson | AstraZeneca |
| Principal Investigator: | Tracy Batchelor, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Jane Robertson, Medical Science Director, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00503204 History of Changes |
| Other Study ID Numbers: | D8480C00057, EuDract 2007-000909-30 |
| Study First Received: | July 16, 2007 |
| Last Updated: | November 24, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
cancer tumor advance solid tumour glioblastoma malignant brain tumour |
Additional relevant MeSH terms:
|
Brain Neoplasms Glioblastoma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Astrocytoma Glioma Neoplasms, Neuroepithelial |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Lomustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013