Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: cediranib (RECENTIN TM, AZD2171)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00750425

EUDRACT number 2008-002271-27

D8480C00020

Details and patient eligibility

About

Phase I, open study to assess the effect of ketoconazole, a marketed drug, on the way the body handles the experimental drug cediranib, in patients with advanced cancer.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Histological or cytological confirmation of advanced solid tumour (with the exception of prostate cancer), which is refractory to standard therapies or for which no standard therapy exists.
• Estimated life expectancy of at least 8 weeks
• WHO performance status (PS) 0-2.

Exclusion criteria

• Unstable brain/meningeal metastases
• Biochemistry/haematology results outside of required ranges
• History of significant GI impairment
• Inadequate bone marrow reserve

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

1

Experimental group

Description:

Cediranib alone, followed by cediranib plus ketoconazole, followed by cediranib alone

Treatment:

Drug: cediranib (RECENTIN TM, AZD2171)