Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours

AstraZeneca

Status and phase: Active, not recruiting; Phase 1

Conditions: Solid Tumors

Treatments: Drug: cediranib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00750841

2008-002519-42

D8480C00029

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• 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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

1

Experimental group

Description:

Cediranib alone, followed by cediranib plus rifampicin, followed by cediranib alone.

Treatment:

Drug: cediranib