Metastatic Hormone Refractory Prostate CancerPhase 2NCT00766324
PHA-739358 for Treatment of Hormone Refractory Prostate Cancer
A Phase 2 study testing PHA-739358 in people with Metastatic Hormone Refractory Prostate Cancer, run by Nerviano Medical Sciences at 1 site in Italy.
Trial summary
To assess the antitumor activity of PHA-739358 administered as IV infusion according to two different dose schedules in metastatic HRPC patients progressing on standard, docetaxel-based 1st-line chemotherapy for HRPC based on PSA response, and to select the best dose schedule for further investigation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone Refractory Prostate Cancer
- What is being tested?
- PHA-739358
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2007to Apr 2011
- Phase
- Phase 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
- Metastatic hormone refractory prostate cancer progressing after docetaxel based therapy
- Adequate bone marrow, liver and kidney function
Who cannot join
- More than one prior chemotherapy line
- Uncontrolled hypertension
- Brain or leptomeningeal disease
- Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months
Trial locations and contacts
1 site in 1 country.
Italy1 site
Nerviano Medical Sciences. Clinical Research Dept.
Nerviano, Milano, 20014
About this study
Official title: A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer
To assess the antitumor activity of PHA-739358 administered as IV infusion according to two different dose schedules in metastatic HRPC patients progressing on standard, docetaxel-based 1st-line chemotherapy for HRPC based on PSA response, and to select the best dose schedule for further investigation.
- Being tested
- PHA-739358
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHA-739358Drug
6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle
PHA-739358Drug
24-hr IV infusion every 2 weeks in a 4-week cycle
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: PHA-739358 |
| B | Experimental | Not described Receives: Drug: PHA-739358 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group
Measured: within the first three months of treatment
Secondary outcomes (2)
Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit
Measured: all cycles
Overall safety profile
Measured: all cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startSep 2007
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone Refractory 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nerviano Medical Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766324
- Sponsor's protocol ID
- AURA-6202-007
- Status last verified
- May 2014
- First submitted
- 2 Oct 2008
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00766324
- Acronym / sponsor ID
- AURA-6202-007
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Nerviano Medical SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 3 Oct 2008 (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.
To assess the antitumor activity of PHA-739358 administered as IV infusion according to two different dose schedules in metastatic HRPC patients progressing on standard, docetaxel-based 1st-line chemotherapy for HRPC based on PSA response, and to select the best dose schedule for further investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: PHA-739358 |
| B | Experimental | Drug: PHA-739358 |
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)
- Metastatic hormone refractory prostate cancer progressing after docetaxel based therapy
- Adequate bone marrow, liver and kidney function
Key exclusion criteria (4 listed)
- More than one prior chemotherapy line
- Uncontrolled hypertension
- Brain or leptomeningeal disease
- Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months
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 |
|---|---|---|
| PHA-7393586-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle | Drug | A |
| PHA-73935824-hr IV infusion every 2 weeks in a 4-week cycle | Drug | B |
Primary outcome
PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group
Time frame: within the first three months of treatment
2 secondary outcomes
Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit
Time frame: all cycles
Overall safety profile
Time frame: all cycles
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 28 May 2014.
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 1/2
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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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)
Metastatic Castration-resistant Prostate Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PHA-739358 in people with Metastatic Hormone Refractory Prostate Cancer, run by Nerviano Medical Sciences at 1 site in Italy.
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 4 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 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
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?
PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group (time frame: within the first three months of treatment). 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 28 May 2014.