Phase I Orally Administered 14C-AZD2171 in Patients With Solid Metastatic Tumors - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00503412

Purpose

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.

Condition	Intervention	Phase
Advanced Solid Metastatic Tumor	Drug: AZD2171	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Cediranib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	6
Study Start Date:	November 2005
Study Completion Date:	May 2006

Intervention Details:

oral 14C

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503412

Locations

United Kingdom
Research Site
Sutton, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Nick Botwood, BSc, MBBS, MRCP, MFPM	AstraZeneca
Principal Investigator:	Stan Kaye, Prod	Royal Marsden NHS Foundation Trust

More Information

Study ID Numbers:	D8480C00019
Study First Received:	July 16, 2007
Last Updated:	December 15, 2007
ClinicalTrials.gov Identifier:	NCT00503412
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

phase I
AZD2171
solid tumor
metastatic tumor

Study placed in the following topic categories:

Neoplasm Metastasis

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009