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

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.
 
ClinicalTrials.gov Identifier: NCT00750841
Recruitment Status : Active, not recruiting
First Posted : September 11, 2008
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: cediranib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : September 9, 2008
Actual Primary Completion Date : July 30, 2009
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750841


Locations
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Canada, Alberta
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H3T 1E2
United Kingdom
Research Site
Dundee, United Kingdom, DD1 9SY
Research Site
Glasgow, United Kingdom, G12 0YN
Research Site
London, United Kingdom, NW1 2PG
Research Site
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Michael Sawyer, MD Cross Cancer Institute, Edmonton, AB, Canada
Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00750841    
Other Study ID Numbers: D8480C00029
2008-002519-42
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Keywords provided by AstraZeneca:
advanced cancer
metastatic
rifampicin
pharmacokinetics
Phase I
Advanced solid tumours
Additional relevant MeSH terms:
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Neoplasms
Cediranib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action