Prostate CancerPhase 1/2NCT01284920
A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients
A Phase 1/2 study testing MDV3100 in people with Prostate Cancer and Prostate Neoplasms, run by Astellas Pharma Inc at 7 sites in Japan.
Trial summary
This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Neoplasms, Castration Resistant Prostate Cancer (CRPC)
- What is being tested?
- MDV3100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 7 sitesJapan
- Study dates
- 2 Nov 2010to 2 Jul 2014
- Phase
- Phase 1/2
- 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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Ongoing androgen deprivation therapy with a GnRH analogue or a bilateral orchiectomy
- Progressive disease after prior androgen deprivation therapy (medical or surgical castration)
- For Expansion Cohort, the patient has no more than two prior chemotherapy regimens with at least one regimen containing docetaxel
- For Expansion Cohort, the patient must have measurable lesions by RECIST
Who cannot join
- Metastases in the brain
- History of another malignancy except for adenocarcinoma of the prostate within the previous 5 years
- Use of bicalutamide within 6 weeks prior to study
- Radiation therapy within 12 weeks prior to study
- Evidence of serious drug hypersensitivity
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaido
Study site
Kansai
Study site
Kanto
Study site
Kyusyu
Study site
Shikoku
About this study
Official title: A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer
This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.
Read the detailed description
This is a Phase1/2, open-label, uncontrolled study, involving Dose-Escalation Cohorts, where dose will be escalated to next dose with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients and an Expansion Cohort, where the efficacy, safety, and PK of MDV3100 in post-chemo mCRPC patients will be evaluated. After evaluation of the safety and tolerability in Dose-Escalation Cohorts, additional patients are included in Expansion Cohort.
- Being tested
- MDV3100
- Keywords
- docetaxel, Response Evaluation Criteria in Solid Tumor (RECIST), PSA level, 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.
MDV3100Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| dose-escalation cohort-1 | Experimental | MDV3100 low dose arm Receives: Drug: MDV3100 |
| dose-escalation cohort-2 | Experimental | MDV3100 middle dose arm Receives: Drug: MDV3100 |
| dose-escalation cohort-3 | Experimental | MDV3100 high dose arm Receives: Drug: MDV3100 |
| dose-expansion cohort | Experimental | dose expansion with MDV3100 middle dose Receives: Drug: MDV3100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC
This measure will be assessed on the dose escalation cohorts.
Measured: 3 months during the study
Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
This measure will be assessed on the dose expansion cohort
Measured: Day 85 and end of long term dosing period
Secondary outcomes (2)
Prostate Specific Antigen (PSA) Response
Measured: Day 85 and end of long term dosing period
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG
This measure will be assessed on the dose expansion cohort.
Measured: 3 months during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study start2 Nov 2010
- Primary completion12 Jul 2012
- Study completion2 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284920
- Sponsor's protocol ID
- 9785-CL-0111
- Status last verified
- Nov 2024
- First submitted
- 18 Jan 2011
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Akaza H, Uemura H, Tsukamoto T, Ozono S, Ogawa O, Sakai H, Oya M, Namiki M, Fukasawa S, Yamaguchi A, Uemura H, Ohashi Y, Maeda H, Saito A, Takeda K, Naito S. A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer. Int J Clin Oncol. 2016 Aug;21(4):773-782. doi: 10.1007/s10147-016-0952-6. Epub 2016 Jan 21.
PubMed 26793974
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01284920
- Acronym / sponsor ID
- 9785-CL-0111
- Keywords
- docetaxel, Response Evaluation Criteria in Solid Tumor (RECIST), PSA level, MDV3100
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
- Study start
- 2 Nov 2010 (actual)
- Primary completion
- 12 Jul 2012 (actual)
- Study completion
- 2 Jul 2014 (actual)
- First posted
- 27 Jan 2011 (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.
This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.
Detailed description
This is a Phase1/2, open-label, uncontrolled study, involving Dose-Escalation Cohorts, where dose will be escalated to next dose with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients and an Expansion Cohort, where the efficacy, safety, and PK of MDV3100 in post-chemo mCRPC patients will be evaluated. After evaluation of the safety and tolerability in Dose-Escalation Cohorts, additional patients are included in Expansion Cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| dose-escalation cohort-1 | Experimental | Drug: MDV3100MDV3100 low dose arm |
| dose-escalation cohort-2 | Experimental | Drug: MDV3100MDV3100 middle dose arm |
| dose-escalation cohort-3 | Experimental | Drug: MDV3100MDV3100 high dose arm |
| dose-expansion cohort | Experimental | Drug: MDV3100dose expansion with MDV3100 middle dose |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Ongoing androgen deprivation therapy with a GnRH analogue or a bilateral orchiectomy
- Progressive disease after prior androgen deprivation therapy (medical or surgical castration)
- For Expansion Cohort, the patient has no more than two prior chemotherapy regimens with at least one regimen containing docetaxel
- For Expansion Cohort, the patient must have measurable lesions by RECIST
Key exclusion criteria (5 listed)
- Metastases in the brain
- History of another malignancy except for adenocarcinoma of the prostate within the previous 5 years
- Use of bicalutamide within 6 weeks prior to study
- Radiation therapy within 12 weeks prior to study
- Evidence of serious drug hypersensitivity
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 |
|---|---|---|
| MDV3100oral | Drug | dose-escalation cohort-1, dose-escalation cohort-2, dose-escalation cohort-3, dose-expansion cohort |
Primary outcome
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC
Time frame: 3 months during the study
This measure will be assessed on the dose escalation cohorts.
Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Day 85 and end of long term dosing period
This measure will be assessed on the dose expansion cohort
2 secondary outcomes
Prostate Specific Antigen (PSA) Response
Time frame: Day 85 and end of long term dosing period
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG
Time frame: 3 months during the study
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 21 Nov 2024.
- Derived from this study: PubMed 26793974Akaza H, Uemura H, Tsukamoto T, Ozono S, Ogawa O, Sakai H, Oya M, Namiki M, Fukasawa S, Yamaguchi A, Uemura H, Ohashi Y, Maeda H, Saito A, Takeda K, Naito S. A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer. Int J Clin Oncol. 2016 Aug;21(4):773-782. doi: 10.1007/s10147-016-0952-6. Epub 2016 Jan 21.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Use Central Contact study chair
Astellas Pharma Inc
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MDV3100 in people with Prostate Cancer and Prostate Neoplasms, run by Astellas Pharma Inc at 7 sites in Japan.
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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. 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 combined 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.
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?
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?
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC (time frame: 3 months during the study). 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?
On the ClinicalTrials.gov record for NCT01284920, which also lists 1 linked publication.
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 21 Nov 2024.