- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00423332
Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma
December 8, 2016 updated by: AstraZeneca
A Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib 45mg Versus Placebo Following 12 Weeks of Treatment in Patients With Metastatic or Recurrent Renal Cell Carcinoma Who Have Had no Previous Anti-VEGF Therapy.
Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Groningen, Netherlands
- Research Site
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Leiden, Netherlands
- Research Site
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Nijmegen, Netherlands
- Research Site
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Birmingham, United Kingdom
- Research Site
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London, United Kingdom
- Research Site
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Manchester, United Kingdom
- Research Site
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Northwood, United Kingdom
- Research Site
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Oxford, United Kingdom
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmation of metastatic or recurrent renal cell carcinoma
Exclusion Criteria:
- Certain types of previous anti-cancer therapy for Renal Cell Carcinoma
- Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes
- Patients with a history of poorly controlled high blood pressure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: 1
Cediranib placebo
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oral tablet
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EXPERIMENTAL: 2
Cediranib
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45 mg oral tablet
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change From Baseline in Tumour Size at 12 Weeks
Time Frame: Baseline to Week 12
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Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)*100
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Baseline to Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Best Percentage Change From Baseline in Tumour Size During the Study
Time Frame: Treatment period up to Week 12 visit date for last patient in (LPI)
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Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions
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Treatment period up to Week 12 visit date for last patient in (LPI)
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Duration of Response
Time Frame: Treatment period up to 2nd data cut-off of 8th March 2009
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Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point.
Measured from the time the criteria for complete response (CR)/partial response (PR) are first met (whichever is recorded first) until the patient progresses or dies.
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Treatment period up to 2nd data cut-off of 8th March 2009
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Progression Free Survival
Time Frame: Treatment period up to 2nd data cut-off of 8th March 2009.
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Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
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Treatment period up to 2nd data cut-off of 8th March 2009.
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Objective Tumour Response at 12 Weeks
Time Frame: Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12.
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Number of patients with complete (CR) /partial response (PR) (based on RECIST).
CR is defined as Disappearance of all target lesions.
PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.
At 12 weeks, tumour responses would be unconfirmed, as this was the first post-baseline RECIST assessment, unless a patient had a RECIST assessment before Week 12 to confirm a suspected progression.
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Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12.
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Best Objective Tumour Response
Time Frame: Baseline, Week 12 and every 8 weeks thereafter or until progression.
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Best Objective Tumour response as defined by RECIST.
Patients were assigned to 1 of the following best objective tumour response categories: complete response (CR) defined as a Disappearance of all target lesions, partial response (PR), defined as At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD, stable disease (SD) defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, or progressive disease (PD) defined as At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).
Patients who were evaluable for RECIST assessments, but who did not meet the criteria for CR, PR, SD, or PD, were assigned to the response category of not evaluable (NE).
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Baseline, Week 12 and every 8 weeks thereafter or until progression.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (ACTUAL)
March 1, 2008
Study Completion (ACTUAL)
October 1, 2016
Study Registration Dates
First Submitted
January 16, 2007
First Submitted That Met QC Criteria
January 16, 2007
First Posted (ESTIMATE)
January 18, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
February 2, 2017
Last Update Submitted That Met QC Criteria
December 8, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Cediranib
Other Study ID Numbers
- D8480C00030
- EudraCT no. 2006-002455-33
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Australian and New Zealand Urogenital and Prostate...RecruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11.2 Translocation-Related Renal Cell CarcinomaAustralia
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National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell CarcinomaUnited States
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Bradley A. McGregor, MDBristol-Myers Squibb; ExelixisRecruitingRenal Cell Carcinoma | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Collecting Duct Renal Cell Carcinoma | Translocation Renal Cell Carcinoma | Unresectable Advanced Renal Cell Carcinoma | Metastatic Ncc Renal Cell CarcinomaUnited States
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Memorial Sloan Kettering Cancer CenterActive, not recruitingChromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma | Fumarate Hydratase Deficient Renal Cell Carcinoma | Succinate Dehydrogenase Deficient Renal Cell Carcinoma | Collecting Duct Renal...United States
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Australian and New Zealand Urogenital and Prostate...Bristol-Myers SquibbActive, not recruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11 Translocation CarcinomaAustralia
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Peloton Therapeutics, Inc.Active, not recruitingKidney Cancer | Renal Cell Carcinoma | Renal Cancer | Renal Cell Carcinoma (RCC) | Renal Cell Cancer Metastatic | Kidney | Clear Cell Renal Cell Carcinoma (ccRCC) | Renal Cell Carcinoma Recurrent | Renal Cell Cancer, RecurrentUnited States
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AmgenCompletedRenal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | Clear Cell Renal Carcinoma | Renal Cell AdenocarcinomaFrance, United States, Germany
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AstraZenecaCompletedRecurrent GlioblastomaUnited States, Australia, France, United Kingdom, Germany, Netherlands, Canada, Austria, Belgium, Czech Republic
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National Cancer Institute (NCI)CompletedFallopian Tube Cancer | Primary Peritoneal Serous Adenocarcinoma | Recurrent Ovarian Epithelial Cancer | Stage I Ovarian Epithelial Cancer | Stage II Ovarian Epithelial CancerUnited States
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National Cancer Institute (NCI)CompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Recurrent Adult Brain TumorUnited States
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National Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic LeukemiaUnited States
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AstraZenecaCompletedAdvanced Solid TumorsDenmark, Canada