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NCT00750841 Clinical Trial

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

Solid Tumors Clinical Trial

Official title:
A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Rifampicin on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTIN™), in Patients With Advanced Solid Tumours

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00750841
Other study ID # D8480C00029
Secondary ID 2008-002519-4220
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date September 9, 2008
Est. completion date December 31, 2024

Study information
Verified date April 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 64
Est. completion date December 31, 2024
Est. primary completion date July 30, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• cediranib
45 mg cediranib once daily from Days 1-7; cediranib 45 mg plus 600 mg rifampicin from Days 8-14; 45 mg cediranib once daily from Days 15-28; from Day 29 patients may continue on 45 mg cediranib or dose reduce.

Locations
Country Name City State
Canada Research Site Edmonton Alberta
Canada Research Site Montreal Quebec
United Kingdom Research Site Glasgow
United Kingdom Research Site London
United Kingdom Research Site London

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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