Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00475956

Purpose

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.

Condition	Intervention	Phase
Neoplasms	Drug: AZD2171 Drug: AZD0530	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Cancer

Drug Information available for: Cediranib AZD0530

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530 [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]
Safety and efficacy [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]
Genetic variation of pathways targeted by AZD2171 and AZD0530 [ Time Frame: assessed during study ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD2171 Monotherapy	Drug: AZD2171 oral tablet multiple ascending doses 20, 30 or 45 mg
2: Experimental AZD2171 + AZD0530	Drug: AZD2171 oral tablet multiple ascending doses 20, 30 or 45 mg Drug: AZD0530 oral tablet multiple ascending doses 125 mg or 175 mg

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475956

Locations

Germany, Baden-Wurttemberg
Research Site
Freiburg, Baden-Wurttemberg, Germany
Germany, Ruhr
Research Site
Essen, Ruhr, Germany
Research Site
Herne, Ruhr, Germany

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Jane Roberston	AstraZeneca
Principal Investigator:	Tanja Trarbach, MD	Universitatsklinikum der GHS Essen

More Information

No publications provided

Responsible Party:	AstraZeneca ( Jane Robertson, MSD )
Study ID Numbers:	D8480C00014, EuDract #2006-003505-55
Study First Received:	May 18, 2007
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00475956 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

Cancer
Tumour
Advanced Solid Tumour
Lung Cancer
Breast Cancer
Cholangiocarcinoma
Colon Cancer

Gastric Cancer
Choriocarcinoma
Liver Cancer
Myeloma
Ovarian Cancer
Pancreatic Cancer
Peritoneal Cancer

Study placed in the following topic categories:

Liver Neoplasms
Cholangiocarcinoma
Ovarian Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms

Choriocarcinoma
Ovarian Cancer
Breast Neoplasms
Stomach Cancer
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009