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A Study to Determine the Pharmacokinetics of Cediranib in Chinese Patients With Advanced Solid Malignancies

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00981721
First received: September 21, 2009
Last updated: June 17, 2011
Last verified: June 2011
History of Changes
  Purpose

This study is being carried out to see how single and multiple doses of cediranib are handled by the body (that is how they are absorbed, broken down and got rid of from the body) by measuring levels of drug in the blood in Chinese patients with advanced solid malignancies.

The study will also assess the tolerability of 20 or 30 mg cediranib in Chinese patients and how the tumour responds to treatment with cediranib.


Condition Intervention Phase
Advanced Solid Malignancies
 Drug: cediranib (RECENTIN TM, AZD2171)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Randomised, Multi-centre, Open-label Study to Determine the Pharmacokinetics and Tolerability of Cediranib (RECENTIN™, AZD2171) Following a Single and Multiple Oral 20mg or 30 mg Doses in Chinese Patients With Advanced Solid Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the pharmacokinetics of single dose of cediranib 20mg or 30 mg by assessment of area under the curve over the time (AUC) and maximum concentration in Chinese patients with advanced solid malignant tumours [ Time Frame: Multiple assessments in the first 6 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the pharmacokinetics of multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignant tumours [ Time Frame: Multiple assessments up to day 29 ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of single and multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignancies. [ Time Frame: Safety assessments to be taken until Day 29 (while patient remains on study treatment), then every 4 weeks until treatment discontinuation and then 30 day follow up ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: September 2009
Study Completion Date: April 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
cediranib 20mg
 Drug: cediranib (RECENTIN TM, AZD2171)
20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8
Experimental: 2
cediranib 30mg
 Drug: cediranib (RECENTIN TM, AZD2171)
20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8

  Eligibility

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

Inclusion Criteria:

  • Provision of informed consent
  • Histological and/or cytological confirmed advanced solid malignancies
  • Refractory to conventional therapeutic modalities, or for which no appropriate therapies exist

Exclusion Criteria:

  • For the first question: Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of antihypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilize blood pressure.
  • Significant haemorrhage (>30 ml/bleeding episode in previous 3 months), haemoptysis (>5 ml fresh blood in previous 4 weeks) or thrombotic event (including transient ischaemic attack) in the previous 12 months
  • Recent(<28 days) major thoracic and abdominal surgery prior to entry into the study, or a surgical incision that is not fully healed.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981721

Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Hong Kong
Research Site
Hong Kong, Hong Kong, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jeannie Hou AstraZeneca China MC
Principal Investigator: Sun Yan, Prof Cancer Hospital, CAMS&PUMC, China
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00981721     History of Changes
Other Study ID Numbers: D8480C00060
Study First Received: September 21, 2009
Last Updated: June 17, 2011
Health Authority: China: Food and Drug Administration
Hong Kong: Department of Health

Keywords provided by AstraZeneca:
Phase I
Advanced solid malignancies
Advanced solid tumour
Advanced cancer
 Cediranib (RECENTIN™, AZD2171)
China
PK
pharmacokinetics

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013