Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours
- Registration Number
- NCT00750841
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 64
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.
Read More
Exclusion Criteria
- Unstable brain/meningeal metastases
- Biochemistry/haematology results outside of required ranges
- History of significant GI impairment
- Inadequate bone marrow reserve
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 cediranib Cediranib alone, followed by cediranib plus rifampicin, followed by cediranib alone.
- Primary Outcome Measures
Name Time Method To assess the steady-state PK parameters of cediranib in the presence and absence of rifampicin PK assessments to be taken until Day 28. Days 7 and 14 PK parameters used to assess the primary variables.
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of cediranib in the presence of rifampicin, by assessment of Adverse events (AEs) Laboratory findings, Vital signs, physical examination and Electrocardiogram. Until study drug is discountinued
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom