Prostate CancerPhase 2NCT00585416
Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer
A Phase 2 study testing CGC-11047 in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this research is to determine the effectiveness of CGC-11047 in subjects with metastatic hormone refractory prostate cancer as measured by changes in PSA. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- CGC-11047
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Mar 2009
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.
- testosterone <50ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
- Progressive disease after androgen deprivation.
Who cannot join
- Patients whose clinical condition would make chemotherapy clearly indicated.
- Patients who have received systemic chemotherapy for the treatment of metastatic disease.
- Peripheral neuropathy > Grade 1
- Prior anti-angiogenic therapy, including thalidomide.
- Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure or radiation within 4 weeks prior to study entry.
- Patients who have received radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
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- Patients with known brain metastases or history of brain metastases.
- History of stroke within 6 months of treatment or other significant neurological limitations.
- Patients who have received more than 2 prior investigational treatments.
- Uncontrolled intercurrent illness
- Patients with a history of a myocardial infarction within the prior 6 months or, hospitalizations for decompensated congestive heart failure within the prior 6 months, or history of significant / symptomatic cardiac arrhythmias
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: A Phase II Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer (47-02-001)
The purpose of this research is to determine the effectiveness of CGC-11047 in subjects with metastatic hormone refractory prostate cancer as measured by changes in PSA.
- Conditions
- Prostate Cancer
- Being tested
- CGC-11047
- Keywords
- Prostate Cancer, Hormone Refractory, Metastatic
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGC-11047Drug
CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle) Receives: Drug: CGC-11047 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Measured: 8 weeks
Secondary outcomes (1)
Safety
Measured: Throughout and for 28 days post drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startJun 2006
- Primary completionNov 2007
- Study completionMar 2009
Why it stopped: Further evaluation of phase I dosing
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.
- More trials run by University of Wisconsin, MadisonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Progen Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585416
- Sponsor's protocol ID
- HSC2006-0099
- Other IDs
- CO06801, 47-02-001
- Status last verified
- Apr 2009
- First submitted
- 21 Dec 2007
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer (47-02-001)
- ClinicalTrials.gov ID
- NCT00585416
- Acronym / sponsor ID
- HSC2006-0099
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Hormone Refractory, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Further evaluation of phase I dosing
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Progen Pharmaceuticals
- Study start
- Jun 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 3 Jan 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.
The purpose of this research is to determine the effectiveness of CGC-11047 in subjects with metastatic hormone refractory prostate cancer as measured by changes in PSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CGC-11047CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Metastatic hormone refractory prostate cancer.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.
- testosterone <50ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
- Progressive disease after androgen deprivation.
Key exclusion criteria (11 listed)
- Patients whose clinical condition would make chemotherapy clearly indicated.
- Patients who have received systemic chemotherapy for the treatment of metastatic disease.
- Peripheral neuropathy > Grade 1
- Prior anti-angiogenic therapy, including thalidomide.
- Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure or radiation within 4 weeks prior to study entry.
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 |
|---|---|---|
| CGC-11047CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle) | Drug | 1 |
Primary outcome
Efficacy
Time frame: 8 weeks
1 secondary outcome
Safety
Time frame: Throughout and for 28 days post drug
Results and safety
The study was stopped early (reason given: Further evaluation of phase I dosing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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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.
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 CGC-11047 in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site 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 4 inclusion and 11 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 2 Oct 2015. 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 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 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: Further evaluation of phase I dosing). 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?
Efficacy (time frame: 8 weeks). 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 2 Oct 2015.