Prostate CancerPhase 1NCT00510718

A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer

A Phase 1 study testing MDV3100 in people with Prostate Cancer and Hormone Refractory Prostate Cancer, run by Pfizer at 9 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

This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Read more about this study

Who is it for?: Any age, men only
Conditions the study is for: Prostate Cancer, Hormone Refractory Prostate Cancer
What is being tested?: MDV3100
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 9 sitesUnited States
Study dates: 23 Jul 2007to 2 Apr 2018
Phase: Phase 1
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 Any age
Men only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Histologically or cytologically confirmed adenocarcinoma of the prostate;
Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);
Progressive disease after medical or surgical castration,

Who cannot join

1. Metastases in the brain or active epidural disease. (Note: patients with treated epidural disease are allowed);

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215
Investigational Pharmacy Services
Houston, Texas, 77030-4009
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030-4009
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
MSKCC- Sidney Kimmel Center
New York, New York, 10065
Oregon Health & Science University
Portland, Oregon, 97239
Seattle Cancer Care Alliance
Seattle, Washington, 98109
University of Washington Medical Center
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: A PHASE 1, OPEN-LABEL, DOSE-ESCALATION SAFETY AND PHARMACOKINETIC STUDY OF MDV3100 IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER

Read the detailed description

This is a Phase 1, open-label, uncontrolled, dose-escalation study with dose-expansion at doses determined to be tolerated. Patients who tolerate the drug and do not progress will be allowed to continue treatment. The study endpoints are safety and tolerability and pharmacokinetics. PSA values will also be collected to look for PSA response.

Conditions: Prostate Cancer, Hormone Refractory Prostate Cancer
Being tested: MDV3100
Keywords: Prostate, Cancer, Hormone, Refractory, Castration
Medical subject headings: Prostatic Neoplasms, Neoplasms

What participants receive

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

MDV3100Drug
Also called enzalutamide, Xtandi
MDV3100 daily until progression or dose-limiting toxicity

Study groups in NCT00510718
Study group	Role	What they receive
1	Experimental	MDV3100 Receives: Drug: MDV3100

What is being measured

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

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
An adverse events (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both SAEs and non-SAEs.
Measured: Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Percentage of Participants With at Least 1 Dose-limiting Toxicity (DLT): Multiple Dose Period
DLT was defined as a national cancer institute's common toxicity criteria for adverse events (NCI-CTCAE) version 3.0 grade 3 or greater toxicity regardless of perceived causality that is not improved by the use of adequate/maximal medical intervention. Grade 3 alopecia, fever without neutropenia, nausea, vomiting, fatigue, and self-limited or medically controllable adverse events were not considered as DLTs.
Measured: Baseline up to first 35 days of the study treatment in multiple dose period
Maximum Tolerated Dose (MTD) of MDV3100: Multiple Dose Period
Tolerability was defined as if less than (<) 4/12 in participants with no prior exposure to MDV3100 (chemo-naive) and < 4/12 prior chemotherapy participants experienced a DLT within the first 35 days of the multiple dose period. For doses higher than 360 mg/day, tolerability was defined if <8/24 participants previously treated with chemotherapy experience a DLT within the first 35 days of the multiple dose period. MTD was defined as a dose below the intolerable dose.
Measured: Baseline up to first 35 days of the study treatment in multiple dose period

Secondary outcomes (13)

Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Single Dose Period
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post dose on Day 1 of Single Dose Period
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of MDV3100: Single Dose Period
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours postdose on Day 1 of Single Dose Period
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of MDV3100: Single Dose Period
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Single Dose Period
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Maximum Plasma Concentration (Cmax) of MDV3100: Single Dose Period
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Apparent Terminal Elimination Half-Life (T1/2) of MDV3100: Single Dose Period
T 1/2 is the time measured for the plasma concentration of MDV3100 to decrease by one half.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Apparent Volume of Distribution (V/F) of MDV3100: Single Dose Period
Volume of distribution is defined as the theoretical volume in which the total amount of MDV3100 would need to be uniformly distributed to produce the desired plasma concentration of MDV3100. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Apparent Total Plasma Clearance (CL/F) of MDV3100: Single Dose Period
Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Multiple Dose Period
Measured: Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Multiple Dose Period
Measured: Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
Maximum Plasma Concentration (Cmax) of MDV3100: Multiple Dose Period
Measured: Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
Minimum Observed Plasma Concentration (Cmin) of MDV3100: Multiple Dose Period
Measured: Pre-dose on Day 1 of Multiple Dose Period
Apparent Total Plasma Clearance (CL/F) of MDV3100: Multiple Dose Period
Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Measured: Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period

Timeline

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

23 Jul 20072 Apr 2018

First posted2 Aug 2007 (estimated)
Study start23 Jul 2007
Primary completion8 Dec 2008
Study completion2 Apr 2018

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by PfizerThe 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
Masking: None (open label)
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00510718
Sponsor's protocol ID: S-3100-1-01
Other IDs: C3431009
Status last verified: Sep 2019
First submitted: 31 Jul 2007
Last updated: 3 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.
PubMed 25917876
Scher HI, Beer TM, Higano CS, Anand A, Taplin ME, Efstathiou E, Rathkopf D, Shelkey J, Yu EY, Alumkal J, Hung D, Hirmand M, Seely L, Morris MJ, Danila DC, Humm J, Larson S, Fleisher M, Sawyers CL; Prostate Cancer Foundation/Department of Defense Prostate Cancer Clinical Trials Consortium. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. Lancet. 2010 Apr 24;375(9724):1437-46. doi: 10.1016/S0140-6736(10)60172-9. Epub 2010 Apr 14.
PubMed 20398925

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?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, DOSE-ESCALATION SAFETY AND PHARMACOKINETIC STUDY OF MDV3100 IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER
ClinicalTrials.gov ID: NCT00510718
Acronym / sponsor ID: S-3100-1-01
Conditions: Prostate Cancer, Hormone Refractory Prostate Cancer
Keywords: Prostate, Cancer, Hormone, Refractory, Castration
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: Astellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Study start: 23 Jul 2007 (actual)
Primary completion: 8 Dec 2008 (actual)
Study completion: 2 Apr 2018 (actual)
First posted: 2 Aug 2007 (estimated)
Results: Posted 3 Oct 2019

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: MDV3100MDV3100

Who may qualify

Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Histologically or cytologically confirmed adenocarcinoma of the prostate;
Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);
Progressive disease after medical or surgical castration,

Key exclusion criteria (1 listed)

1. Metastases in the brain or active epidural disease. (Note: patients with treated epidural disease are allowed);

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
MDV3100Also: enzalutamide, XtandiMDV3100 daily until progression or dose-limiting toxicity	Drug	1

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Time frame: Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
An adverse events (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both SAEs and non-SAEs.
Percentage of Participants With at Least 1 Dose-limiting Toxicity (DLT): Multiple Dose Period
Time frame: Baseline up to first 35 days of the study treatment in multiple dose period
DLT was defined as a national cancer institute's common toxicity criteria for adverse events (NCI-CTCAE) version 3.0 grade 3 or greater toxicity regardless of perceived causality that is not improved by the use of adequate/maximal medical intervention. Grade 3 alopecia, fever without neutropenia, nausea, vomiting, fatigue, and self-limited or medically controllable adverse events were not considered as DLTs.
Maximum Tolerated Dose (MTD) of MDV3100: Multiple Dose Period
Time frame: Baseline up to first 35 days of the study treatment in multiple dose period
Tolerability was defined as if less than (<) 4/12 in participants with no prior exposure to MDV3100 (chemo-naive) and < 4/12 prior chemotherapy participants experienced a DLT within the first 35 days of the multiple dose period. For doses higher than 360 mg/day, tolerability was defined if <8/24 participants previously treated with chemotherapy experience a DLT within the first 35 days of the multiple dose period. MTD was defined as a dose below the intolerable dose.

13 secondary outcomes

Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Single Dose Period
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post dose on Day 1 of Single Dose Period
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of MDV3100: Single Dose Period
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours postdose on Day 1 of Single Dose Period
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of MDV3100: Single Dose Period
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Single Dose Period
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Maximum Plasma Concentration (Cmax) of MDV3100: Single Dose Period
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Apparent Terminal Elimination Half-Life (T1/2) of MDV3100: Single Dose Period
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Apparent Volume of Distribution (V/F) of MDV3100: Single Dose Period
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Apparent Total Plasma Clearance (CL/F) of MDV3100: Single Dose Period
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Multiple Dose Period
Time frame: Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Multiple Dose Period
Time frame: Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
Maximum Plasma Concentration (Cmax) of MDV3100: Multiple Dose Period
Time frame: Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
Minimum Observed Plasma Concentration (Cmin) of MDV3100: Multiple Dose Period
Time frame: Pre-dose on Day 1 of Multiple Dose Period
Apparent Total Plasma Clearance (CL/F) of MDV3100: Multiple Dose Period
Time frame: Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period

Results and safety

Results posted to the registry on 3 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MDV3100 (Enzalutamide): No Previous Chemotherapy	15	15
MDV3100 (Enzalutamide): Post Chemotherapy	12	12

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)

Time frame: Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months). Count of participants. Unit: Participants

Measure	MDV3100 (Enzalutamide) 30 mg/Day n = 3	MDV3100 (Enzalutamide) 60 mg /Day n = 27	MDV3100 (Enzalutamide) 150/160 mg/Day n = 28	MDV3100 (Enzalutamide) 240 mg /Day n = 29	MDV3100 (Enzalutamide) 360 mg /Day n = 28	MDV3100 (Enzalutamide) 480 mg /Day n = 22	MDV3100 (Enzalutamide) 600 mg /Day n = 3	MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period n = 18
Value	0	6	14	8	6	1	1	10

Population analysed: Safety population included all enrolled participants who received at least 1 dose of study drug.

Primary outcome: Percentage of Participants With at Least 1 Dose-limiting Toxicity (DLT): Multiple Dose Period

Time frame: Baseline up to first 35 days of the study treatment in multiple dose period. Number. Unit: percentage of participants

Measure	MDV3100 (Enzalutamide) 30 mg/Day n = 3	MDV3100 (Enzalutamide) 60 mg /Day n = 27	MDV3100 (Enzalutamide) 150/160 mg/Day n = 28	MDV3100 (Enzalutamide) 240 mg /Day n = 29	MDV3100 (Enzalutamide) 360 mg /Day n = 28	MDV3100 (Enzalutamide) 480 mg /Day n = 22	MDV3100 (Enzalutamide) 600 mg /Day n = 3
Value	0	0	0	0	1	1	2

Population analysed: Safety population included all enrolled participants who received at least 1 dose of study drug.

Primary outcome: Maximum Tolerated Dose (MTD) of MDV3100: Multiple Dose Period

Time frame: Baseline up to first 35 days of the study treatment in multiple dose period. Number. Unit: milligrams per day

Measure	MDV3100 (Enzalutamide) : All Participants n = 140
Value	240

Population analysed: Safety population included all enrolled participants who received at least 1 dose of study drug.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MDV3100 (Enzalutamide) 30 mg/Day	0 of 3 (0%)	3 of 3 (100%)	Not reported
MDV3100 (Enzalutamide) 60 mg /Day	6 of 27 (22.2%)	27 of 27 (100%)	Not reported
MDV3100 (Enzalutamide) 150/160 mg/Day	14 of 28 (50%)	27 of 28 (96.4%)	Not reported
MDV3100 (Enzalutamide) 240 mg /Day	8 of 29 (27.6%)	29 of 29 (100%)	Not reported
MDV3100 (Enzalutamide) 360 mg /Day	6 of 28 (21.4%)	28 of 28 (100%)	Not reported
MDV3100 (Enzalutamide) 480 mg /Day	1 of 22 (4.5%)	21 of 22 (95.5%)	Not reported
MDV3100 (Enzalutamide) 600 mg /Day	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period	10 of 18 (55.6%)	17 of 18 (94.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25917876Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.
Derived from this study: PubMed 20398925Scher HI, Beer TM, Higano CS, Anand A, Taplin ME, Efstathiou E, Rathkopf D, Shelkey J, Yu EY, Alumkal J, Hung D, Hirmand M, Seely L, Morris MJ, Danila DC, Humm J, Larson S, Fleisher M, Sawyers CL; Prostate Cancer Foundation/Department of Defense Prostate Cancer Clinical Trials Consortium. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. Lancet. 2010 Apr 24;375(9724):1437-46. doi: 10.1016/S0140-6736(10)60172-9. Epub 2010 Apr 14.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer Pfizer CT.gov Call Center study director

Pfizer

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MDV3100 in people with Prostate Cancer and Hormone Refractory Prostate Cancer, run by Pfizer at 9 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 3 inclusion and 1 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 3 Oct 2019. 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. 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?

Yes. Results are posted in the registry (first posted 3 Oct 2019). 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?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) (time frame: Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)). The study lists 3 primary outcomes in all. 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 NCT00510718, which also lists 2 linked publications.

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 3 Oct 2019.