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Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour

Primary Purpose

Recurrent Glioblastoma, Brain Tumor

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Cediranib

Lomustine

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma focused on measuring cancer, tumor, advance solid tumour, glioblastoma, malignant brain tumour

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site
Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Lomustine + Cediranib (AZD2171)

Outcomes

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.

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

Full Information

NCT ID

NCT00503204

First Posted

July 16, 2007

Last Updated

November 24, 2009

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00503204

Brief Title

Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour

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 Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Glioblastoma, Brain Tumor

Keywords

cancer, tumor, advance solid tumour, glioblastoma, malignant brain tumour

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Lomustine + Cediranib (AZD2171)

Intervention Type

Drug

Intervention Name(s)

Cediranib

Other Intervention Name(s)

RECENTIN™, AZD2171

Intervention Description

oral tablet

Intervention Type

Drug

Intervention Name(s)

Lomustine

Other Intervention Name(s)

CCNU, CeeNU®

Intervention Description

oral capsule

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jane Robertson

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Tracy Batchelor, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

Country

United States

Facility Name

Research Site

City

Sutton

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour

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