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

NCT00981721 | Completed Phase 1

• 1 other identifier: D8480C00060
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advanced Solid Malignancies

Keywords

Phase I; Advanced solid malignancies; Advanced solid tumour; Advanced cancer; Cediranib (RECENTIN™, AZD2171); China; PK; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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

  Multiple assessments in the first 6 days

Secondary Outcomes (2)

• To assess the pharmacokinetics of multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignant tumours

  Multiple assessments up to day 29

• To assess the safety and tolerability of single and multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignancies.

  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

Study Arms (2)

1

EXPERIMENTAL

cediranib 20mg

Drug: cediranib (RECENTIN TM, AZD2171)

2

EXPERIMENTAL

cediranib 30mg

Drug: cediranib (RECENTIN TM, AZD2171)

Interventions

cediranib (RECENTIN TM, AZD2171) DRUG

20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Beijing, Beijing Municipality, China

Location

Research Site

Hong Kong, Hong Kong, China

Location

MeSH Terms

Interventions

cediranib

Study Officials

• Jeannie Hou

  AstraZeneca China MC

  STUDY DIRECTOR

• Sun Yan, Prof

  Cancer Hospital, CAMS&PUMC, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 22, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: April 1, 2011
• Last Updated: June 20, 2011

Record last verified: 2011-06

Locations

CN (2)