Prostate CancerPhase 2IPI-504-04NCT00564928
A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer
A Phase 2 study testing IPI-504 in people with Prostate Cancer and Prostatic Neoplasms, run by Infinity Pharmaceuticals, Inc. at 10 sites in United States.
Trial summary
To determine: Anti-tumor activity of IPI-504 in 2 groups of subjects with hormone resistant prostate cancer. Group A - subjects who have not previously received chemotherapy Group B - sujects who have received prior chemotherapy or could not tolerate chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasms, Cancer of the Prostate
- What is being tested?
- IPI-504
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2007to Jul 2010
- 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
- Adenocarcinoma of the prostate
- Resolution of acute toxic side effects of prior chemotherapy
- Castration resistant disease despite ongoing chemical or surgical castration
- ECOG 0-1
- PSA greater than or equal to 2
- Group A -
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- No Prior treatment for prostate cancer with cytotoxic chemotherapy (neoadjuvant, adjuvant treatment permitted if more than 2 years out)
- Group B
- Radiographic evidence of metastatic disease
- Prior tx with docetaxel-minimum of 2 cycles with progression by RECIST or PSA or intolerant of tx
- Maximum of 3 prior chemotherapies
Who cannot join
- Small cell carcinoma of the prostate
- Treatment within 2 weeks with approved, investigational, or small molecule
- Treatment within 4 weeks with biologic or external beam radiation
- ANC <1,500 cells m3; Platelets <100,000 mm3; Hemoglobin <9.0g/dL
- AST/ALT >2.5 ULN
- Serum creatinine >3.0mg/dL
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- Active keratitis or keratoconjunctivitis
- Previous treatment with 17-AAG, DMAG; or any other HSP-90 inhibitor
- Baseline Qtc >450 mses
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
MCG Cancer Center
Augusta, Georgia, 30912
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Chicago Hospitals
Chicago, Illinois, 60637
Parkland Hospital
Dallas, Texas, 75390
University of Colorado at Denver
Denver, Colorado, 80045
Wayne State University
Detroit, Michigan, 48201
San Bernardino Urological Associates
San Bernardino, California, 92404
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Phase 2 Open-Label Study to Investigate the Pharmacodynamics and Clinical Activity of IPI-504 in Patients With Castration-Resistant Prostate Cancer Stratified by Prior Chemotherapy
To determine:
- Anti-tumor activity of IPI-504 in 2 groups of subjects with hormone resistant prostate cancer.
- Group A - subjects who have not previously received chemotherapy
- Group B - sujects who have received prior chemotherapy or could not tolerate chemotherapy.
- Clinical response will be determined by PSA and radiological response
Read the detailed description
IPI-504 is a novel, water-soluble analog of 17-AAG and a potent inhibitor of Hsp90. Hsp90's role in the cell is to control the proper folding, function, and viability of various "client" proteins. Many of these client proteins (such as AKT, Her-2, Bcr-Abl, PDGFR-α, and c-Kit) are oncoproteins or important cell signaling proteins. Inhibition of HSP-90 leads to the proteasomal degradation of these proteins.
In patients with HRPC,there are several proteins that are important in the progression of HRPC, including AR, AKT and Her-2. All of these are client proteins of Hsp90 and in response to Hsp90 inhibition are degraded by their proteasome. Preclinical studies have shown that Hsp90 inhibition causes a dose dependent degradation of these client proteins and growth inhibition of prostate cancer in xenograft tumors.
- Conditions
- Prostate Cancer, Prostatic Neoplasms, Cancer of the Prostate
- Being tested
- IPI-504
- Keywords
- Hormone resistant prostate cancer, castrate resistant prostate cancer, HRPC, CRPC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-504Drug
IPI-504 at 400mg/m2, IV, 2 times a week for 2 weeks with 10 days off treatment. Twenty-one (21) day cycle
| Study group | Role | What they receive |
|---|---|---|
| IPI-504: Group A | Experimental | No Prior treatment for prostate cancer with cytotoxic chemotherapy (adjuvant or neoadjuvant chemotherapy is acceptable if completed >2 years prior to study) Receives: Drug: IPI-504 |
| IPI-504: Group B | Experimental | * Must have evidence of radiographic metastatic disease
* Must have been treated with a docetaxel-based chemotherapy regimen for HRPC with a minimum of 2 cycles with either PSA or RECIST defined radiographic progression during or witin 60 days of completeing docetaxel based chemotheraph or be intolerant of docetaxel-based chemotherapy
* No more than three prior chemotherapies regimens for HRPC Receives: Drug: IPI-504 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate prior treatment status with clinical response as determined by PSA and radiologic response rate
Measured: 12 Weeks
Secondary outcomes (1)
Assess the safety and tolerability of IPI-504 in patients with hormone resistant prostate cancer
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionMar 2010
- Study completionJul 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infinity Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Oh, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564928
- Sponsor's protocol ID
- IPI-504-04
- Acronym
- IPI-504-04
- Status last verified
- Dec 2012
- First submitted
- 27 Nov 2007
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label Study to Investigate the Pharmacodynamics and Clinical Activity of IPI-504 in Patients With Castration-Resistant Prostate Cancer Stratified by Prior Chemotherapy
- ClinicalTrials.gov ID
- NCT00564928
- Acronym / sponsor ID
- IPI-504-04 / IPI-504-04
- Conditions
- Prostate Cancer, Prostatic Neoplasms, Cancer of the Prostate
- Keywords
- Hormone resistant prostate cancer, castrate resistant prostate cancer, HRPC, CRPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Infinity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 29 Nov 2007 (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 determine:
- Anti-tumor activity of IPI-504 in 2 groups of subjects with hormone resistant prostate cancer.
- Group A - subjects who have not previously received chemotherapy
- Group B - sujects who have received prior chemotherapy or could not tolerate chemotherapy.
- Clinical response will be determined by PSA and radiological response
Detailed description
IPI-504 is a novel, water-soluble analog of 17-AAG and a potent inhibitor of Hsp90. Hsp90's role in the cell is to control the proper folding, function, and viability of various "client" proteins. Many of these client proteins (such as AKT, Her-2, Bcr-Abl, PDGFR-α, and c-Kit) are oncoproteins or important cell signaling proteins. Inhibition of HSP-90 leads to the proteasomal degradation of these proteins.
In patients with HRPC,there are several proteins that are important in the progression of HRPC, including AR, AKT and Her-2. All of these are client proteins of Hsp90 and in response to Hsp90 inhibition are degraded by their proteasome. Preclinical studies have shown that Hsp90 inhibition causes a dose dependent degradation of these client proteins and growth inhibition of prostate cancer in xenograft tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPI-504: Group A | Experimental | Drug: IPI-504No Prior treatment for prostate cancer with cytotoxic chemotherapy (adjuvant or neoadjuvant chemotherapy is acceptable if completed >2 years prior to study) |
| IPI-504: Group B | Experimental | Drug: IPI-504* Must have evidence of radiographic metastatic disease * Must have been treated with a docetaxel-based chemotherapy regimen for HRPC with a minimum of 2 cycles with either PSA or RECIST defined radiographic progression during or witin 60 days of completeing docetaxel based chemotheraph or be intolerant of docetaxel-based chemotherapy * No more than three prior chemotherapies regimens for HRPC |
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)
- Adenocarcinoma of the prostate
- Resolution of acute toxic side effects of prior chemotherapy
- Castration resistant disease despite ongoing chemical or surgical castration
- ECOG 0-1
- PSA greater than or equal to 2
Key exclusion criteria (9 listed)
- Small cell carcinoma of the prostate
- Treatment within 2 weeks with approved, investigational, or small molecule
- Treatment within 4 weeks with biologic or external beam radiation
- ANC <1,500 cells m3; Platelets <100,000 mm3; Hemoglobin <9.0g/dL
- AST/ALT >2.5 ULN
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 |
|---|---|---|
| IPI-504IPI-504 at 400mg/m2, IV, 2 times a week for 2 weeks with 10 days off treatment. Twenty-one (21) day cycle | Drug | IPI-504: Group A, IPI-504: Group B |
Primary outcome
Correlate prior treatment status with clinical response as determined by PSA and radiologic response rate
Time frame: 12 Weeks
1 secondary outcome
Assess the safety and tolerability of IPI-504 in patients with hormone resistant prostate cancer
Time frame: 12 Weeks
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 11 Dec 2012.
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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.
William Oh, MD principal investigator
Dana-Farber Cancer Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPI-504 in people with Prostate Cancer and Prostatic Neoplasms, run by Infinity Pharmaceuticals, Inc. at 10 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 11 inclusion and 9 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 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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?
Correlate prior treatment status with clinical response as determined by PSA and radiologic response rate (time frame: 12 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 11 Dec 2012.