Prostate CancerPhase 1NCT00314782
Phase I Study of ZD4054 (Zibotentan) and Docetaxel in Patients With Metastatic HRPC
A Phase 1 study testing ZD4054 (Zibotentan) and Docetaxel in people with Prostate Cancer, run by AstraZeneca at 9 sites in 3 countries.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ZD4054 (Zibotentan) and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Mar 2006to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States3 sites
Research Site
Buffalo, New York
Research Site
Greenville, South Carolina
Research Site
Nashville, Tennessee
United Kingdom3 sites
Research Site
London
Research Site
Plymouth
Research Site
Surrey
About this study
Official title: 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)
- Conditions
- Prostate Cancer
- Being tested
- ZD4054 (Zibotentan), Docetaxel, Placebo
- Keywords
- metastatic hormone-refractory prostate cancer (HRPC)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD4054 (Zibotentan)Drug
Also called Zibotentan
oral tablet
DocetaxelDrug
Also called Taxotere®
intravenous infusion
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Part A (dose-finding): ZD4054 (Zibotentan) 10 mg oral tablet once daily, with docetaxel 75mg/m^2 intravenous infusion once per cycle Receives: Drug: ZD4054 (Zibotentan); Drug: Docetaxel |
| Part A (ZD4054 (Zibotentan) 15 mg + docetaxel) | Experimental | Part A (dose-finding): ZD4054 (Zibotentan) 15 mg oral tablet once daily, with docetaxel 75mg/m^2 intravenous infusion once per cycle Receives: Drug: ZD4054 (Zibotentan); Drug: Docetaxel |
| Part B | Experimental | 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 Receives: Drug: ZD4054 (Zibotentan); Drug: Docetaxel |
| Part B (placebo) | Experimental | Part B (randomised, placebo-controlled): Matching placebo oral tablet once daily, with docetaxel 75mg/m^2 intravenous infusion once per cycle Receives: Drug: Docetaxel; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Maximum Tolerated Dose (MTD)
Measured: Part A: Cycle 1 ('Primary analysis' corresponding to data cut-off 5th March 2008)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca Emerging Oncology Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314782
- Sponsor's protocol ID
- D4320C00020
- Other IDs
- 4054IL/0020
- Status last verified
- Mar 2010
- First submitted
- 13 Apr 2006
- Last updated
- 12 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00314782
- Acronym / sponsor ID
- D4320C00020
- Conditions
- Prostate Cancer
- Keywords
- metastatic hormone-refractory prostate cancer (HRPC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: ZD4054 (Zibotentan), Drug: DocetaxelPart A (dose-finding): ZD4054 (Zibotentan) 10 mg oral tablet once daily, with docetaxel 75mg/m^2 intravenous infusion once per cycle |
| Part A (ZD4054 (Zibotentan) 15 mg + docetaxel) | Experimental | Drug: ZD4054 (Zibotentan), Drug: DocetaxelPart A (dose-finding): ZD4054 (Zibotentan) 15 mg oral tablet once daily, with docetaxel 75mg/m^2 intravenous infusion once per cycle |
| Part B | Experimental | Drug: ZD4054 (Zibotentan), Drug: DocetaxelPart 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 |
| Part B (placebo) | Experimental | Drug: Docetaxel, Drug: PlaceboPart B (randomised, placebo-controlled): Matching placebo oral tablet once daily, with docetaxel 75mg/m^2 intravenous infusion once per cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZD4054 (Zibotentan)Also: Zibotentanoral tablet | Drug | Part A, Part A (ZD4054 (Zibotentan) 15 mg + docetaxel), Part B |
| DocetaxelAlso: Taxotere®intravenous infusion | Drug | Part A, Part A (ZD4054 (Zibotentan) 15 mg + docetaxel), Part B, Part B (placebo) |
| Placebo | Drug | Part B (placebo) |
Primary outcome
Part A: Maximum Tolerated Dose (MTD)
Time frame: Part A: Cycle 1 ('Primary analysis' corresponding to data cut-off 5th March 2008)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Emerging Oncology Medical Science Director, MD study director
AstraZeneca
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZD4054 (Zibotentan) and Docetaxel in people with Prostate Cancer, run by AstraZeneca at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Maximum Tolerated Dose (MTD) (time frame: Part A: Cycle 1 ('Primary analysis' corresponding to data cut-off 5th March 2008)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2013.