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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00750841
First Posted: September 11, 2008
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
September 10, 2008
September 11, 2008
September 19, 2017
September 9, 2008
July 30, 2009   (Final data collection date for primary outcome measure)
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. ]
Same as current
Complete list of historical versions of study NCT00750841 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumors
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.
Other Name: RECENTIN
Experimental: 1
Cediranib alone, followed by cediranib plus rifampicin, followed by cediranib alone.
Intervention: Drug: cediranib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
65
December 29, 2017
July 30, 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 130 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United Kingdom
 
 
NCT00750841
D8480C00029
2008-002519-42
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Jane Robertson AstraZeneca, Alderley Park
Principal Investigator: Michael Sawyer, MD Cross Cancer Institute, Edmonton, AB, Canada
AstraZeneca
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP