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: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Drug: cediranib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 88
Study Start Date: September 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cediranib alone, followed by cediranib plus rifampicin, followed by cediranib alone.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750841

Locations
Canada, Alberta
Research Site
Edmonton, Alberta, Canada
Canada, Quebec
Research Site
Montreal, Quebec, Canada
United Kingdom
Research Site
Dundee, United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson AstraZeneca, Alderley Park
Principal Investigator: Michael Sawyer, MD Cross Cancer Institute, Edmonton, AB, Canada
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00750841     History of Changes
Other Study ID Numbers: D8480C00029, 2008-002519-42
Study First Received: September 10, 2008
Last Updated: July 14, 2014
Health Authority: Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
advanced cancer
metastatic
rifampicin
pharmacokinetics
Phase I
Advanced solid tumours

Additional relevant MeSH terms:
Neoplasms
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014