Castrate Resistant Prostate CancerPhase 1/2NCT01352208
Phase I/II Study of ASP9521 in Castrate-Resistant Prostate Cancer (CRPC) Patients
A Phase 1/2 study testing ASP9521 in people with Castrate Resistant Prostate Cancer, run by Astellas Pharma Inc at 4 sites in 3 countries.
Trial summary
The study has three parts. Part 1 is a dose escalation to investigate the safety and tolerability of ASP9521. Part 2 will evaluate the safety and tolerability and initial anti-tumor activity of ASP9521. Part 3 of the study will be a Food Effect study. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castrate Resistant Prostate Cancer
- What is being tested?
- ASP9521
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Mar 2011to Sep 2012
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
- Metastatic disease documented by 2 or more bone lesions on bone scan or by soft tissue disease observed by Computed tomography/Magnetic resonance imaging (CT/MRI)
- Ongoing androgen deprivation with Luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy or bilateral orchiectomy. For patients who have not had an orchiectomy, there must be a plan to maintain effective LHRH agonist/antagonist therapy for the duration of the study
- Serum testosterone <1.7 nmol/L (50 ng/dL) at screening
- Patients receiving bisphosphonates or other approved bone targeting therapy must have been on stable doses for at least 4 weeks prior to screening
- Progressive disease at study entry defined as one or more of the following 3 criteria occurring in the setting of castrate levels of testosterone:
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- Prostate-specific antigen (PSA) progression defined by a minimum of 2 rising PSA levels with an interval of >1 week between each determination. The PSA value at screening should be >2 ng/mL
- Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST). Measurable disease is not required for entry. Lymph nodes >20 mm are considered measurable disease
- Bone disease progression defined by at least 2 new lesions on bone scan
- Life expectancy of >6 months according to the investigator's judgment
- Chemotherapy-Naïve patients should be asymptomatic or controlled symptomatic patients with metastatic CRPC who have failed one or more lines of hormonal treatment/androgen deprivation therapy but have not received chemotherapy or have refused chemotherapy. Post chemotherapy patients should have received not more than two prior regimens of chemotherapy for prostate cancer, of which one is docetaxel-based
Who cannot join
- Concomitant treatment with the following is prohibited:
- All biologic agents (except for sipuleucel T [Provenge®]), or other agents with anti-tumor activity against prostate cancer, including 5 alpha reductase inhibitors, androgens (e.g., testosterone), cytoproterone acetate and all other progestational agents, estrogens, and flutamide within 4 weeks prior to screening
- Bicalutamide or nilutamide within 6 weeks prior to screening
- Treatment with estramustine
- Ketoconazole for treatment of prostate cancer
- Treatment with abiraterone
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- Radiation therapy for treatment of the prostate within 3 months prior to screening
- Radiation therapy for the treatment of metastases within 3 weeks (if single fraction of radiotherapy then within 2 weeks) and radionuclide therapy for the treatment of metastases within 4 weeks prior to screening
- Major surgery within 2 months prior to screening
- Known or suspected intracerebral disease or brain metastasis
- Use of an investigational agent within 4 weeks prior to treatment allocation or a period required by local regulation, whichever is longer
- Prior use, or participation in a clinical study, of an investigational agent that blocks androgen synthesis or targets the androgen receptor
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
About this study
Official title: Phase I/II, Multi-center, Open Label, Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of ASP9521 in Patients With Metastatic Castrate-resistant Prostate Cancer
The study has three parts. Part 1 is a dose escalation to investigate the safety and tolerability of ASP9521. Part 2 will evaluate the safety and tolerability and initial anti-tumor activity of ASP9521. Part 3 of the study will be a Food Effect study.
Read the detailed description
The purpose of the first study part is to investigate the safety and tolerability of ASP9521 in patients with Castrate Resistant Prostate Cancer. This will be done at different doses, starting at the lowest dose up to higher doses to find the maximum dose that is tolerated.
The second part will investigate the safety and tolerability and evaluate initial anti-tumor activity of ASP9521. This will be done at multiple doses which are identified in part 1 to potentially be effective. The number of patients in part 2 will be higher number compared to part I.
The third part of the study will investigate the effect of food on the drug in patients; this will be a crossover design fed to fasted and vice versa.
- Conditions
- Castrate Resistant Prostate Cancer
- Being tested
- ASP9521
- Keywords
- ASP9521, Castrate Resistant Prostate Cancer, Phase 1/2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP9521Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP9521 | Experimental | Not described Receives: Drug: ASP9521 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability, based on the frequency and severity of Adverse Events (AEs), laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations
Measured: Up to day 28 and further
Secondary outcomes (1)
Decline in Prostate-specific antigen (PSA)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: It was decided to discontinue the development in consideration of the results of a P1 study
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 Castrate Resistant 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352208
- Sponsor's protocol ID
- 9521-CL-0002
- Other IDs
- 2010-023382-22
- Status last verified
- Dec 2012
- First submitted
- 14 Apr 2011
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Loriot Y, Fizazi K, Jones RJ, Van den Brande J, Molife RL, Omlin A, James ND, Baskin-Bey E, Heeringa M, Baron B, Holtkamp GM, Ouatas T, De Bono JS. Safety, tolerability and anti-tumour activity of the androgen biosynthesis inhibitor ASP9521 in patients with metastatic castration-resistant prostate cancer: multi-centre phase I/II study. Invest New Drugs. 2014 Oct;32(5):995-1004. doi: 10.1007/s10637-014-0101-x. Epub 2014 Apr 27.
PubMed 24771350
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II, Multi-center, Open Label, Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of ASP9521 in Patients With Metastatic Castrate-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01352208
- Acronym / sponsor ID
- 9521-CL-0002
- Conditions
- Castrate Resistant Prostate Cancer
- Keywords
- ASP9521, Castrate Resistant Prostate Cancer, Phase 1/2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was decided to discontinue the development in consideration of the results of a P1 study
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 May 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.
The study has three parts. Part 1 is a dose escalation to investigate the safety and tolerability of ASP9521. Part 2 will evaluate the safety and tolerability and initial anti-tumor activity of ASP9521. Part 3 of the study will be a Food Effect study.
Detailed description
The purpose of the first study part is to investigate the safety and tolerability of ASP9521 in patients with Castrate Resistant Prostate Cancer. This will be done at different doses, starting at the lowest dose up to higher doses to find the maximum dose that is tolerated.
The second part will investigate the safety and tolerability and evaluate initial anti-tumor activity of ASP9521. This will be done at multiple doses which are identified in part 1 to potentially be effective. The number of patients in part 2 will be higher number compared to part I.
The third part of the study will investigate the effect of food on the drug in patients; this will be a crossover design fed to fasted and vice versa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP9521 | Experimental | Drug: ASP9521 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
- Metastatic disease documented by 2 or more bone lesions on bone scan or by soft tissue disease observed by Computed tomography/Magnetic resonance imaging (CT/MRI)
- Ongoing androgen deprivation with Luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy or bilateral orchiectomy. For patients who have not had an orchiectomy, there must be a plan to maintain effective LHRH agonist/antagonist therapy for the duration of the study
- Serum testosterone <1.7 nmol/L (50 ng/dL) at screening
- Patients receiving bisphosphonates or other approved bone targeting therapy must have been on stable doses for at least 4 weeks prior to screening
Key exclusion criteria (12 listed)
- Concomitant treatment with the following is prohibited:
- Radiation therapy for treatment of the prostate within 3 months prior to screening
- Radiation therapy for the treatment of metastases within 3 weeks (if single fraction of radiotherapy then within 2 weeks) and radionuclide therapy for the treatment of metastases within 4 weeks prior to screening
- Major surgery within 2 months prior to screening
- Known or suspected intracerebral disease or brain metastasis
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 |
|---|---|---|
| ASP9521oral | Drug | ASP9521 |
Primary outcome
To evaluate the safety and tolerability, based on the frequency and severity of Adverse Events (AEs), laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations
Time frame: Up to day 28 and further
1 secondary outcome
Decline in Prostate-specific antigen (PSA)
Time frame: Week 12
Results and safety
The study was stopped early (reason given: It was decided to discontinue the development in consideration of the results of a P1 study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
- Derived from this study: PubMed 24771350Loriot Y, Fizazi K, Jones RJ, Van den Brande J, Molife RL, Omlin A, James ND, Baskin-Bey E, Heeringa M, Baron B, Holtkamp GM, Ouatas T, De Bono JS. Safety, tolerability and anti-tumour activity of the androgen biosynthesis inhibitor ASP9521 in patients with metastatic castration-resistant prostate cancer: multi-centre phase I/II study. Invest New Drugs. 2014 Oct;32(5):995-1004. doi: 10.1007/s10637-014-0101-x. Epub 2014 Apr 27.
Related trials for Castrate Resistant Prostate Cancer
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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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 director
Astellas Pharma Europe B.V.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ASP9521 in people with Castrate Resistant Prostate Cancer, run by Astellas Pharma Inc at 4 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 11 inclusion and 12 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: stopped early, as of the sponsor's last update on 24 Mar 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 Kingdom, Belgium, France. 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 was stopped early (reason given: It was decided to discontinue the development in consideration of the results of a P1 study). Results are not available in the source record.
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?
To evaluate the safety and tolerability, based on the frequency and severity of Adverse Events (AEs), laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations (time frame: Up to day 28 and further). 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 NCT01352208, 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 24 Mar 2014.