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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00750841

Enrollment

Registered

2008-09-11

Start date

2008-09-09

Completion date

2026-12-31

Last updated

2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Keywords

advanced cancer, metastatic, rifampicin, pharmacokinetics, Phase I, Advanced solid tumours

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.

Interventions

DRUGcediranib

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 130 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Canada, United Kingdom

Contacts

PRINCIPAL_INVESTIGATORMichael Sawyer, MD

Cross Cancer Institute, Edmonton, AB, Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026