- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00314782
Phase I Study of ZD4054 (Zibotentan) and Docetaxel in Patients With Metastatic HRPC
March 11, 2013 updated by: AstraZeneca
A Phase I Study of ZD4054 (Zibotentan) in Combination With Docetaxel in 2 Parts, an Open-Label, Non-Randomized, Dose-Finding Part and a Double-Blind, Placebo-Controlled, Randomized Dose Expansion Part, in Patients With Metastatic Hormone-Refractory Prostate Cancer
Two-part, multi-center study design to establish a maximum tolerated dose (MTD) of ZD4054 in combination with docetaxel and to explore its safety, tolerability, pharmacokinetic (PK) profiles and clinical efficacy in patients with metastatic hormone-refractory prostate cancer (HRPC)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany
- Research Site
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Dresden, Germany
- Research Site
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Rostock, Germany
- Research Site
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London, United Kingdom
- Research Site
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Plymouth, United Kingdom
- Research Site
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Surrey, United Kingdom
- Research Site
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New York
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Buffalo, New York, United States
- Research Site
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South Carolina
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Greenville, South Carolina, United States
- Research Site
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Tennessee
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Nashville, Tennessee, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Provision of informed consent
- Histological or cytological confirmation of prostate cancer
- Evidence of metastatic disease on CT scan, MRI, or bone scan
- Surgically or continuously medically castrated with LHRH analogue
Progressive disease after most recent therapy
- Disease progression by CT/MRI
- Bone scan progression: appearance of 1 or more new lesions since last bone scan
- Rising PSA
- World health organization (WHO) performance status 0 to 2
- Life expectancy of 12 weeks or longer
Exclusion Criteria:
- Use of anti-hormonal therapies (including ketoconazole, aminoglutethimide, finasteride and anti-androgen therapies) within 4 weeks of starting study treatment, except for bicalutamide and nilutamide which are excluded within 6 weeks of starting study treatment. Estramustine or estrogens, if taken, have to be stopped at least 4 weeks before starting treatment.
- Definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonist; history of severe hypersensitivity reactions to drugs formulated with polysorbate 80.
- Prior cytotoxic chemotherapy for metastatic prostate cancer
- Radiotherapy within 4 weeks before the start of study therapy
- Systemic radionuclide therapy (ie strontium chloride Sr89, 186Re-labeled HEDP, or 153Sm-EDTMP pentasodium) within 12 weeks before entering study
- Use of potent CYP450 inhibitors (such as itraconazole, ritonavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem, verapamil) within 2 weeks before study entry.
- Use of potent CYP450 inducers (such as phenytoin, rifampicin, carbamazepine and phenobarbitone, St. John's Wort) within 2 weeks before study entry.
NOTE: Dexamethasone is a known inducer of CYP2D6 and CYP3A4 but is not considered exclusionary for purposes of this study.
- New neurologic symptoms or signs consistent with acute or evolving spinal cord compression confirmed by magnetic resonance imaging (MRI) (except for those previously treated and have stable symptoms).
- History of past or current epilepsy, epilepsy syndrome, or other seizure disorder
- History of Migraine or chronic headache
- Symptomatic central nervous system (CNS) metastases
- Absolute Neutrophil Count (ANC) <1.5 x 109/L (1,5000/mm3)
- Platelet count < 100 x 109/L (100,000/mm3)
- Serum bilirubin greater than the upper limit of normal (ULN)
- Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 1.5 times the upper limit of normal (ULN)
- Creatinine clearance <50 mL/min
- QT interval corrected for heart rate by the Barrett Formula (QTc) > 470 msec at screening
- New York Heart Association (NYHA) class II-IV Heart Disease
- Myocardial infarction (heart attack) within past 3 months
- CTCAE grade ≥2 Peripheral Neuropathy
- Treatment with a non-approved or investigational drug within 30 days before study entry
- Evidence of any other significant clinical symptoms, abnormal laboratory findings or recent surgery that patients has not recovered from that make it undesirable for the patient to participate in the study in the opinion of the investigator(s)
- Involvement in the planning and conduct of the study
- Previous treatment in the present study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Part A
Part A (dose-finding): ZD4054 (Zibotentan) 10 mg oral tablet once daily, with docetaxel 75mg/m^2 intravenous infusion once per cycle
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intravenous infusion
Other Names:
oral tablet
Other Names:
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Experimental: Part A (ZD4054 (Zibotentan) 15 mg + docetaxel)
Part A (dose-finding): ZD4054 (Zibotentan) 15 mg oral tablet once daily, with docetaxel 75mg/m^2 intravenous infusion once per cycle
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intravenous infusion
Other Names:
oral tablet
Other Names:
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Experimental: Part B
Part B (randomised, placebo-controlled): ZD4054 (Zibotentan) Maximum Tolerated Dose (MTD), 15mg, oral tablet once daily, with docetaxel 75mg/m^2 intravenous infusion once per cycle
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intravenous infusion
Other Names:
oral tablet
Other Names:
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Experimental: Part B (placebo)
Part B (randomised, placebo-controlled): Matching placebo oral tablet once daily, with docetaxel 75mg/m^2 intravenous infusion once per cycle
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intravenous infusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Part A: Maximum Tolerated Dose (MTD)
Time Frame: Part A: Cycle 1 ('Primary analysis' corresponding to data cut-off 5th March 2008)
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Part A: Cycle 1 ('Primary analysis' corresponding to data cut-off 5th March 2008)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: AstraZeneca Emerging Oncology Medical Science Director, MD, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
April 13, 2006
First Submitted That Met QC Criteria
April 13, 2006
First Posted (Estimate)
April 17, 2006
Study Record Updates
Last Update Posted (Estimate)
March 12, 2013
Last Update Submitted That Met QC Criteria
March 11, 2013
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D4320C00020
- 4054IL/0020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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