Prostate CancerPhase 1NCT01902251
Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients
A Phase 1 study testing Enzalutamide tablet and Enzalutamide capsule in people with Prostate Cancer and Pharmacokinetics of Enzalutamide, run by Astellas Pharma Europe B.V. at 4 sites in United States.
Trial summary
A multiple dose relative bioavailability study in patients with prostate cancer comparing a capsule and a tablet formulation of enzalutamide. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Pharmacokinetics of Enzalutamide
- What is being tested?
- Enzalutamide tablet and Enzalutamide capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2012to Oct 2013
- 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
- Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant setting). Subjects may be on ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration) at study entry.
- Progressive disease by Prostate-specific antigen (PSA) or imaging. Disease progression for study entry is defined as one or more of the following 3 criteria:
- PSA progression defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination. The PSA value during the pre-investigational period should be ≥2 μg/L (2 ng/mL);
- Soft tissue disease progression defined by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) for soft tissue disease
- Bone disease progression defined by two or more new lesions on bone scan
Who cannot join
- Treatment with chemotherapy within 4 weeks prior to enrollment (Day 1 visit) or plans to initiate treatment with chemotherapy during the study.
- History of seizure or any condition that may predispose to seizure. Also, history of loss of consciousness, or transient ischemic attack within 12 months prior to enrollment (Day 1 visit).
- Patients who previously received treatment with Enzalutamide.
- Concomitant use of drugs that are potent inducers and/or inhibitors of CYP3A4 and CYP2C8.
- Confirmed CYP2C8 poor metabolizer status based on genotyping analysis.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Colorado - Anschutz Medical Campus
Denver, Colorado, 80045
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
About this study
Official title: A Phase I, Open-label, Randomized, Parallel, Relative Bioavailability Study Comparing a Capsule and a Tablet Formulation of Enzalutamide Following Multiple Once Daily Doses of 160 mg Enzalutamide in Male Subjects With Prostate Cancer
A multiple dose relative bioavailability study in patients with prostate cancer comparing a capsule and a tablet formulation of enzalutamide.
- Conditions
- Prostate Cancer, Pharmacokinetics of Enzalutamide
- Being tested
- Enzalutamide tablet, Enzalutamide capsule
- Keywords
- Phase 1, Prostate cancer, Bioavailability, Food effect, Pharmacokinetics, Xtandi, Enzalutamide, MDV3100
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzalutamide tabletDrug
Also called Xtandi, MDV3100
Oral
Enzalutamide capsuleDrug
Also called Xtandi, MDV3100
Oral
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide tablet | Experimental | Multiple once daily oral doses of enzalutamide formulated as a tablet for approximately 8 weeks Receives: Drug: Enzalutamide tablet |
| Enzalutamide capsule | Active comparator | Multiple once daily oral doses of enzalutamide formulated as liquid-filled soft gelatin capsule for approximately 8 weeks Receives: Drug: Enzalutamide capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of Enzalutamide under fasted conditions measured by Cmax (Maximum concentration)
Day 56 (fasted) Cmax under steady state conditions of enzalutamide
Measured: Day1 through Day 56 (12 samples)
Pharmacokinetic profile of Enzalutamide under fasted conditions measured by AUC0-24h (Area under the concentration-time curve 0-24h)
Day 56 (fasted) AUC0-24h under steady state conditions of enzalutamide
Measured: Day1 through Day 56 (12 samples)
Secondary outcomes (3)
Pharmacokinetic profile of Enzalutamide under fasted and fed conditions
Measured by: Cmax, tmax (Time to attain Cmax), AUC0-24h, Ctrough (Trough concentration), PTR (Peak-trough ratio), CLss/F (Apparent clearance at steady state)
Measured: Day 1, 8, 29, 55, 56 and 57 (38 samples)
Pharmacokinetic profile of MDPC0001 alone, MDPC0002 alone and sum of Enzalutamide plus MDPC0002
Measured by: Ctrough, Cmax, tmax, AUC0-24h, Ctrough (24h after dosing), PTR
Measured: Day 8, 29, 55, 56 and 57 (26 samples)
Evaluation of the safety and tolerability of two oral formulations of Enzalutamide assessed through vital signs, adverse events, electrocardiogram and clinical laboratory assessments
Measured: Day 1 through Day 58
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startNov 2012
- Primary completionOct 2013
- Study completionOct 2013
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902251
- Sponsor's protocol ID
- 9785-CL-0003
- Status last verified
- Sep 2014
- First submitted
- 15 Jul 2013
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Randomized, Parallel, Relative Bioavailability Study Comparing a Capsule and a Tablet Formulation of Enzalutamide Following Multiple Once Daily Doses of 160 mg Enzalutamide in Male Subjects With Prostate Cancer
- ClinicalTrials.gov ID
- NCT01902251
- Acronym / sponsor ID
- 9785-CL-0003
- Conditions
- Prostate Cancer, Pharmacokinetics of Enzalutamide
- Keywords
- Phase 1, Prostate cancer, Bioavailability, Food effect, Pharmacokinetics, Xtandi, Enzalutamide, MDV3100
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Study start
- Nov 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Jul 2013 (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.
A multiple dose relative bioavailability study in patients with prostate cancer comparing a capsule and a tablet formulation of enzalutamide.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide tablet | Experimental | Drug: Enzalutamide tabletMultiple once daily oral doses of enzalutamide formulated as a tablet for approximately 8 weeks |
| Enzalutamide capsule | Active comparator | Drug: Enzalutamide capsuleMultiple once daily oral doses of enzalutamide formulated as liquid-filled soft gelatin capsule for approximately 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant setting). Subjects may be on ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration) at study entry.
- Progressive disease by Prostate-specific antigen (PSA) or imaging. Disease progression for study entry is defined as one or more of the following 3 criteria:
Key exclusion criteria (5 listed)
- Treatment with chemotherapy within 4 weeks prior to enrollment (Day 1 visit) or plans to initiate treatment with chemotherapy during the study.
- History of seizure or any condition that may predispose to seizure. Also, history of loss of consciousness, or transient ischemic attack within 12 months prior to enrollment (Day 1 visit).
- Patients who previously received treatment with Enzalutamide.
- Concomitant use of drugs that are potent inducers and/or inhibitors of CYP3A4 and CYP2C8.
- Confirmed CYP2C8 poor metabolizer status based on genotyping analysis.
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 |
|---|---|---|
| Enzalutamide tabletAlso: Xtandi, MDV3100Oral | Drug | Enzalutamide tablet |
| Enzalutamide capsuleAlso: Xtandi, MDV3100Oral | Drug | Enzalutamide capsule |
Primary outcome
Pharmacokinetic profile of Enzalutamide under fasted conditions measured by Cmax (Maximum concentration)
Time frame: Day1 through Day 56 (12 samples)
Day 56 (fasted) Cmax under steady state conditions of enzalutamide
Pharmacokinetic profile of Enzalutamide under fasted conditions measured by AUC0-24h (Area under the concentration-time curve 0-24h)
Time frame: Day1 through Day 56 (12 samples)
Day 56 (fasted) AUC0-24h under steady state conditions of enzalutamide
3 secondary outcomes
Pharmacokinetic profile of Enzalutamide under fasted and fed conditions
Time frame: Day 1, 8, 29, 55, 56 and 57 (38 samples)
Pharmacokinetic profile of MDPC0001 alone, MDPC0002 alone and sum of Enzalutamide plus MDPC0002
Time frame: Day 8, 29, 55, 56 and 57 (26 samples)
Evaluation of the safety and tolerability of two oral formulations of Enzalutamide assessed through vital signs, adverse events, electrocardiogram and clinical laboratory assessments
Time frame: Day 1 through Day 58
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 9 Sep 2014.
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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.
Clinical Study Manager study director
Astellas Pharma Europe B.V.
4 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 Enzalutamide tablet and Enzalutamide capsule in people with Prostate Cancer and Pharmacokinetics of Enzalutamide, run by Astellas Pharma Europe B.V. at 4 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 5 inclusion and 5 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 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Pharmacokinetic profile of Enzalutamide under fasted conditions measured by Cmax (Maximum concentration) (time frame: Day1 through Day 56 (12 samples)). The study lists 2 primary outcomes in all. 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 9 Sep 2014.