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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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00750841
First received: September 10, 2008
Last updated: September 23, 2014
Last verified: September 2014

September 10, 2008
September 23, 2014
September 2008
July 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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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
88
December 2014
July 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United Kingdom
 
NCT00750841
D8480C00029, 2008-002519-42
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Jane Robertson AstraZeneca, Alderley Park
Principal Investigator: Michael Sawyer, MD Cross Cancer Institute, Edmonton, AB, Canada
AstraZeneca
September 2014

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