Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours
Phase I, Open-Label Study To Assess the Safety, Tolerability and Pharmacokinetics of Daily Oral Doses of Cediranib (RECENTIN™;AZD2171) (20, 30 or 45mg) When Co-Administered With Daily Oral Doses of AZD0530 (125mg or 175mg) in Patients With Advanced Solid Tumours
2 other identifiers
interventional
40
1 country
3
Brief Summary
The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2007
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 18, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedApril 15, 2010
April 1, 2010
1.4 years
May 18, 2007
April 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the safety and tolerability of ascending daily oral doses of AZD2171 when co-administered with AZD0530 to patients with advanced solid tumours by assessment of AEs, vital signs, HRCT Scans, clin chem, haematology, urinalysis, ECG and phys exam
assessed at each visit
Secondary Outcomes (3)
Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530
assessed at each visit
Safety and efficacy
assessed at each visit
Genetic variation of pathways targeted by AZD2171 and AZD0530
assessed during study
Study Arms (2)
1
EXPERIMENTALAZD2171 Monotherapy
2
EXPERIMENTALAZD2171 + AZD0530
Interventions
Eligibility Criteria
You may qualify if:
- Written consent
- Cancer diagnosis \& stage
- Patients for whom no standard therapy exists
- World Health Organization (WHO) performance status 0-2
- One or more measurable lesions
You may not qualify if:
- Prostate cancer
- Untreated unstable brain or meningeal metastases
- Specific laboratory ranges
- Pregnant or breast-feeding women
- Any evidence of severe or uncontrolled diseases
- Participation in other trials within 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Research Site
Essen, Ruhr, Germany
Research Site
Herne, Ruhr, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jane Roberston
AstraZeneca
- PRINCIPAL INVESTIGATOR
Tanja Trarbach, MD
Universitatsklinikum der GHS Essen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 18, 2007
First Posted
May 21, 2007
Study Start
May 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2009
Last Updated
April 15, 2010
Record last verified: 2010-04