Prostatic NeoplasmsPhase 2NCT00055471

A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer

A Phase 2 study testing ZD4054 10 mg, ZD4054 15 mg and ZD4054 22.5 mg in people with Prostatic Neoplasms and Metastases, Neoplasm, run by AstraZeneca at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostatic Neoplasms, Metastases, Neoplasm
What is being tested?: ZD4054 10 mg, ZD4054 15 mg and ZD4054 22.5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 2 sitesUnited States
Study dates: Jun 2003to Oct 2005
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Men 18 years \& older
Confirmed diagnosis of prostate cancer with bone metastases

Who cannot join

No more than 2 prior chemotherapy regimens
No radiation, chemotherapy or bisphosphonates in the past 4 weeks

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Research Site
Cleveland, Ohio, 44195
Research Site
Madison, Wisconsin

Other trials in United States

About this study

The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer

Conditions: Prostatic Neoplasms, Metastases, Neoplasm
Being tested: ZD4054 10 mg, ZD4054 15 mg, ZD4054 22.5 mg
Keywords: prostate cancer, Metastatic prostate cancer, bone metastases
Medical subject headings: Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZD4054 10 mgDrug
Also called Zibotentan,
1 x 10 mg oral tablets once daily
ZD4054 15 mgDrug
Also called Zibotentan
1 x 10 mg + 2 x 2.5 mg oral tablets once daily
ZD4054 22.5 mgDrug
Also called Zibotentan
2 x 10 mg + 2 x 2.5 mg oral tablets once daily

Study groups in NCT00055471
Study group	Role	What they receive
ZD4054 10 mg	Experimental	1 x 10 mg oral tablets once daily Receives: Drug: ZD4054 10 mg
ZD4054 15 mg	Experimental	1 x 10 mg + 2 x 2.5 mg oral tablets once daily Receives: Drug: ZD4054 15 mg
ZD4054 22.5 mg	Experimental	2 x 10 mg + 1 x 2.5 mg oral tablets once daily Receives: Drug: ZD4054 22.5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose Limiting Toxicities (DLTs)
DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment.
The numbers of patients with a DLT are reported.
Measured: Baseline to Day 29.

Secondary outcomes (6)

Total Prostate Specific Antigen (PSA) Concentration
Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2).
Measured: Baseline to Day 15.
Change in Total Prostate Specific Antigen (PSA)
Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2).
Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100
Measured: Baseline to Day 15.
Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)
Percentage change in serum concentration of Bone Alkaline Phosphatase (ALP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100
Measured: Baseline to Day 15.
Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)
Percentage change in serum concentration of Procollagen Type I N Propeptide (PINP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2).
Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100
Measured: Baseline to Day 15.
Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)
Percentage change in serum concentration of C-Terminal Telopeptide of Type I Collagen (CTx) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100
Measured: Baseline to Day 15.
Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)
Percentage change in urine concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) (nmol BCE/mmol Creatinine) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100
Measured: Baseline to Day 15.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2003Oct 2005

First posted4 Mar 2003 (estimated)
Study startJun 2003
Primary completionOct 2005
Study completionOct 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostatic NeoplasmsStudies 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 2
Primary purpose: Treatment
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00055471
Sponsor's protocol ID: 4054IL/0004
Status last verified: Oct 2012
First submitted: 3 Mar 2003
Last updated: 31 Oct 2012
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
PSA Level Greater Than Two, Stage IV Prostate Adenocarcinoma AJCC v7
RecruitingEarly Phase 1
FTT PET/CT in Metastatic Prostate Cancer
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Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
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RecruitingPhase 2
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Recurrent Prostate Cancer
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
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All Prostatic Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT00055471
Acronym / sponsor ID: 4054IL/0004
Conditions: Prostatic Neoplasms, Metastases, Neoplasm
Keywords: prostate cancer, Metastatic prostate cancer, bone metastases
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2003
Primary completion: Oct 2005 (actual)
Study completion: Oct 2005 (actual)
First posted: 4 Mar 2003 (estimated)
Results: Posted 31 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer

Study design

Primary purpose: Treatment
Number of arms: 3

Arm	Type	Receives
ZD4054 10 mg	Experimental	Drug: ZD4054 10 mg1 x 10 mg oral tablets once daily
ZD4054 15 mg	Experimental	Drug: ZD4054 15 mg1 x 10 mg + 2 x 2.5 mg oral tablets once daily
ZD4054 22.5 mg	Experimental	Drug: ZD4054 22.5 mg2 x 10 mg + 1 x 2.5 mg oral tablets once daily

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Men 18 years \& older
Confirmed diagnosis of prostate cancer with bone metastases

Key exclusion criteria (2 listed)

No more than 2 prior chemotherapy regimens
No radiation, chemotherapy or bisphosphonates in the past 4 weeks

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 10 mgAlso: Zibotentan,1 x 10 mg oral tablets once daily	Drug	ZD4054 10 mg
ZD4054 15 mgAlso: Zibotentan1 x 10 mg + 2 x 2.5 mg oral tablets once daily	Drug	ZD4054 15 mg
ZD4054 22.5 mgAlso: Zibotentan2 x 10 mg + 2 x 2.5 mg oral tablets once daily	Drug	ZD4054 22.5 mg

Primary outcome

Dose Limiting Toxicities (DLTs)
Time frame: Baseline to Day 29.
DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment. The numbers of patients with a DLT are reported.

6 secondary outcomes

Total Prostate Specific Antigen (PSA) Concentration
Time frame: Baseline to Day 15.
Change in Total Prostate Specific Antigen (PSA)
Time frame: Baseline to Day 15.
Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)
Time frame: Baseline to Day 15.
Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)
Time frame: Baseline to Day 15.
Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)
Time frame: Baseline to Day 15.
Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)
Time frame: Baseline to Day 15.

Results and safety

Results posted to the registry on 31 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ZD4054 10 mg	3	3
ZD4054 15 mg	10	8
ZD4054 22.5 mg	3	0

Primary outcome: Dose Limiting Toxicities (DLTs)

Time frame: Baseline to Day 29.. Number. Unit: Participants

Measure	ZD4054 10 mg n = 3	ZD4054 15 mg n = 10	ZD4054 22.5 mg n = 3
Value	0	0	2

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ZD4054 10 mg	0 of 3 (0%)	3 of 3 (100%)	Not reported
ZD4054 15 mg	2 of 10 (20%)	10 of 10 (100%)	Not reported
ZD4054 22.5 mg	2 of 3 (66.7%)	3 of 3 (100%)	Not reported

Limitations and caveats (from the sponsor): One patient received one dose of 22.5 mg and was dose reduced to 15 mg thereafter. This patient was classified into the 15 mg dose group, except for the single dose pharmacokinetic results (not posted).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostatic Neoplasms

Active, not recruitingPhase 2
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
PSA Level Greater Than Two, Stage IV Prostate Adenocarcinoma AJCC v7
RecruitingEarly Phase 1
FTT PET/CT in Metastatic Prostate Cancer
Prostate Cancer Metastatic
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
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RecruitingPhase 2
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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZD4054 10 mg, ZD4054 15 mg and ZD4054 22.5 mg in people with Prostatic Neoplasms and Metastases, Neoplasm, run by AstraZeneca at 2 sites in United States.

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 2 inclusion and 2 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 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Dose Limiting Toxicities (DLTs) (time frame: Baseline to Day 29.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00055471.

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 31 Oct 2012.