10mg ZD4054 (Zibotentan) PK Study in Male, Elderly Chinese Patients With Advanced Solid Malignancies
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00997945
First received: October 19, 2009
Last updated: May 18, 2011
Last verified: May 2011
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Purpose
The purpose of this study is to assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Malignancies |
Drug: ZD4054 (Zibotentan) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Phase I, Open-label, Single-arm Study to Determine the Single and Multiple Dose Pharmacokinetics of 10mg ZD4054 (Zibotentan) Administered Once Daily in Male, Elderly Chinese Patients With Advanced Solid Malignancies |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies [ Time Frame: PK samples will be taken until Day 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess the safety and tolerability of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies [ Time Frame: Safety assessments to be taken until Day 16 (while patient remains on study treatment), then every 8 weeks until treatment discontinuation ] [ Designated as safety issue: Yes ]
| Enrollment: | 15 |
| Study Start Date: | October 2009 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
ZD4054 (Zibotentan) 10mg
|
Drug: ZD4054 (Zibotentan)
10 mg ZD4054 (Zibotentan) once daily on Day1, Day4 to Day15
Other Name: Zibotentan
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provision of informed consent
- Histological and/or cytological confirmed advanced solid malignancies
- WHO performance status<2
Exclusion Criteria:
- History of significant gastrointestinal impairment, as judged by the investigator, that could significantly affect the absorption of ZD4054 (Zibotentan) , including the ability to swallow the tablet whole.
- ALT or AST³2.5 ´ULRR. If liver metastases are present ALT or AST more than 5times ULRR, Serum bilirubin > 1.5 x ULRR, Serum creatinine>1.5 x ULRR or creatinine clearance of <50mL/min calculated by Cockroft-Gault
- Recent (<14 days) major surgery prior to entry into the study, or a surgical incision that is not fully healed, Radical radiotherapy within the previous 4 weeks, or unresolved acute or subacute toxicities from prior radiotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997945
Locations
| China, Shanghai | |
| Research Site | |
| Shanghai, Shanghai, China | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Li Jin | The Cancer Hospital Affiliated Fudan University |
| Study Director: | Helen Lin | AstraZeneca China MC |
More Information
No publications provided
| Responsible Party: | MSD, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00997945 History of Changes |
| Other Study ID Numbers: | D4320C00041 |
| Study First Received: | October 19, 2009 |
| Last Updated: | May 18, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Phase I, advanced solid malignancies, advance solid tumour advanced cancer ZD4054 (Zibotentan) |
china PK pharmacokinetics |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013