- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00503412
Phase I Orally Administered 14C-AZD2171 in Patients With Solid Metastatic Tumors
January 15, 2009 updated by: AstraZeneca
A Phase 1, Open Label, Non-Randomised, Single Centre Pharmacokinetic and Mass Balance Study of Orally Administered 14-C-AZD2171 in Patients With Solid Metastatic Tumours
Open, non-randomised, radiolabelled, single centre study with a total of six patients with solid metastatic tumors to determine the rates and routes of elimination of 14C-AZD2171 and its metabolites.
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
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
-
-
-
Sutton, United Kingdom
- Research Site
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- histologically confirmed metastatic tumor which is refractory to standard therapies
- life expectancy is 12 weeks or longer
- WHO performance status is 0-12
Exclusion Criteria:
- radiotherapy and chemotherapy within 4 weeks before the start of the study treatment
- patients with a history of poorly controlled hypertension
- history or evidence of any medical condition that might affect gastrointestinal function
- patients that have participated in a radiolabelled study in the last 5 years
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary objective is to determine the rates & routes of excretion of 14C radiolabelled AZD2171 in patients by assessment of concentrations of total 14C radioactivity and AZD2171 in plasma & concentrations of total radioactivity in urine&faeces
Time Frame: assessed at time intervals post dose
|
assessed at time intervals post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM, AstraZeneca
- Principal Investigator: Stan Kaye, Prod, Royal Marsden NHS Foundation Trust
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
November 1, 2005
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
July 16, 2007
First Submitted That Met QC Criteria
July 16, 2007
First Posted (Estimate)
July 18, 2007
Study Record Updates
Last Update Posted (Estimate)
January 19, 2009
Last Update Submitted That Met QC Criteria
January 15, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D8480C00019
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.
Clinical Trials on Advanced Solid Metastatic Tumor
-
Jazz PharmaceuticalsMerck Sharp & Dohme LLCRecruitingAdvanced Solid Tumor | Metastatic Solid TumorUnited States
-
PharmaEngineNot yet recruitingAdvanced Solid Tumor | Metastatic Solid Tumor
-
Daiichi SankyoRecruitingAdvanced Solid Tumor | Metastatic Solid TumorUnited States, Japan
-
Jazz PharmaceuticalsActive, not recruitingAdvanced Solid Tumor | Metastatic Solid TumorUnited States
-
Dana-Farber Cancer InstituteCompletedAdvanced Solid Tumor | Metastatic Solid TumorUnited States
-
GI Innovation, Inc.RecruitingAdvanced Solid Tumor | Metastatic Solid TumorKorea, Republic of, United States
-
Xenthera, Inc.Not yet recruitingAdvanced Solid Tumor | Metastatic Solid Tumor
-
Regeneron PharmaceuticalsRecruitingAdvanced Solid Tumor | Metastatic Solid TumorNetherlands
-
Philogen S.p.A.RecruitingAdvanced Solid Tumor | Metastatic Solid TumorItaly, Germany, Switzerland
-
Turning Point Therapeutics, Inc.RecruitingAdvanced Solid Tumor | Metastatic Solid TumorUnited States
Clinical Trials on AZD2171
-
The Christie NHS Foundation TrustAstraZeneca; Cancer Research UKTerminatedRectal CancerUnited Kingdom
-
National Cancer Institute (NCI)CompletedRecurrent Childhood Medulloblastoma | Recurrent Childhood Ependymoma | Childhood Atypical Teratoid/Rhabdoid Tumor | Childhood Grade I Meningioma | Childhood Grade II Meningioma | Childhood Grade III Meningioma | Childhood Infratentorial Ependymoma | Childhood Supratentorial Ependymoma | Recurrent Childhood... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedNeurofibromatosis Type 1 | Plexiform Neurofibroma | Spinal Cord NeurofibromaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Salivary Gland Squamous Cell Carcinoma | Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Recurrent Nasopharyngeal Keratinizing Squamous... and other conditionsUnited States
-
National Cancer Institute (NCI)NRG OncologyCompletedRecurrent Uterine Corpus Carcinoma | Endometrial Clear Cell Adenocarcinoma | Endometrial Serous Adenocarcinoma | Endometrial Adenocarcinoma | Endometrial Adenosquamous CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Recurrent Adult Brain NeoplasmUnited States
-
Peter MacCallum Cancer Centre, AustraliaRecruitingMetastatic Castration-resistant Prostate Cancer | mCRPCAustralia
-
National Cancer Institute (NCI)CompletedRecurrent Renal Cell Carcinoma | Stage IV Renal Cell CancerCanada
-
AstraZenecaCompletedAcute | Leukaemia | Myelocytic
-
Medical Research CouncilNational Health and Medical Research Council, Australia; AstraZeneca; Cancer... and other collaboratorsUnknownOvarian CancerUnited Kingdom