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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00750841
First received: September 10, 2008
Last updated: March 1, 2013
Last verified: March 2013
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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: | 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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | June 2013 |
| 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
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
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: | March 1, 2013 |
| 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 May 23, 2013