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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00475956

Enrollment

Registered

2007-05-21

Start date

2007-05-31

Completion date

2009-10-31

Last updated

2010-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Cancer, Tumour, Advanced Solid Tumour, Lung Cancer, Breast Cancer, Cholangiocarcinoma, Colon Cancer, Gastric Cancer, Choriocarcinoma, Liver Cancer, Myeloma, Ovarian Cancer, Pancreatic Cancer, Peritoneal Cancer

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.

Interventions

DRUGAZD2171

oral tablet multiple ascending doses 20, 30 or 45 mg

DRUGAZD0530

oral tablet multiple ascending doses 125 mg or 175 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026