This trial is active, not recruiting.

Condition solid tumors
Treatment cediranib
Phase phase 1
Target VEGF
Sponsor AstraZeneca
Start date September 2008
End date July 2009
Trial size 88 participants
Trial identifier NCT00750841, 2008-002519-42, D8480C00029


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Cediranib alone, followed by cediranib plus rifampicin, followed by cediranib alone.
cediranib RECENTIN
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.

Primary Outcomes

To assess the steady-state PK parameters of cediranib in the presence and absence of rifampicin
time frame: PK assessments to be taken until Day 28. Days 7 and 14 PK parameters used to assess the primary variables.

Secondary Outcomes

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.
time frame: Until study drug is discountinued

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

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

Additional Information

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
Principal investigator Michael Sawyer, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.