Adenocarcinoma of the ProstatePhase 2NCT01270880
Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
A Phase 2 study testing Hsp90 inhibitor STA-9090, laboratory biomarker analysis and polymerase chain reaction in people with Adenocarcinoma of the Prostate and Hormone-resistant Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 4 sites in United States.
Trial summary
Hsp90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. This phase II trial is studying how well Hsp90 inhibitor STA-9090 works in treating patients with metastatic hormone-resistant prostate cancer previously treated with docetaxel-based chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer
- What is being tested?
- Hsp90 inhibitor STA-9090, laboratory biomarker analysis and polymerase chain reaction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2011to Jul 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pathologically confirmed diagnosis of prostate adenocarcinoma with metastasis and objective progression or rising PSA despite androgen deprivation therapy and antiandrogen withdrawal when applicable
- Progression after docetaxel based chemotherapy is needed as follows:
- a) If measurable disease present, then either rising PSA, increase in size of the lesion/s or both should be present
- b) Patients with rising PSA only as progression must demonstrate a rising trend with 2 successive elevations at minimum intervals of 1 week; a minimum PSA of 5 ng/ml, or new areas of bony metastases on bone scan are required for patients with no measurable disease; no minimum PSA requirement for patients with measurable disease
- Patients should have received at least one prior docetaxel based regimen for metastatic disease; no maximum prior therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
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- Life expectancy of at least 3 months
- Prior radiation therapy or chemotherapy completed at least 28 days prior to enrollment
- All patients must be documented to be castrate with a testosterone level =< 0.5 ng/ml; luteinizing-hormone-releasing hormone (LHRH) agonist therapy must be continued, if required to maintain castrate levels of testosterone; patients must be off antiandrogens for a minimum of 4 weeks for flutamide and 6 weeks for bicalutamide or nilutamide
- Absolute neutrophil count >= 1,500 cells/uL
- Platelets >= 100,000/uL
- Hemoglobin >= 9.0 g/dL
- Serum creatinine =< 1.5 x upper limit of normal (ULN); Note: if serum creatinine is > 1.5 x ULN, subject is eligible if the calculated creatinine clearance (CLcr) is >= 50 mL/min
- Total bilirubin =< 1.5 x ULN
- For patients without documented bone metastases or for patients with liver metastases: transaminases (aspartate aminotransferase [AST]/serum glutamic oxaloacetic transaminase [SGOT] and/or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase [SGPT]) may be up to 2.5 x institutional ULN if alkaline phosphatase is =< ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are =< ULN
- For patients with documented bone metastases, the transaminases (AST/SGOT and/or ALT/SGPT) should be less than 2.5 x institutional ULN, without regard to the alkaline phosphatase level
- Sexually active males must use measures to prevent pregnancy in their partners while on STA-9090
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- Major surgery within 4 weeks prior to first dose of STA-9090
- Poor venous access for study drug administration or would require a peripheral or central indwelling catheter for study drug administration; study drug administration via indwelling catheters is prohibited at this time
- Use of any chemotherapy or other standard systemic treatments for prostate cancer, including investigational agents within 2 weeks or 6 half- lives of the agent, whichever is shorter, prior to receiving STA-9090; there must be at least 2 weeks between the end of palliative radiation and the start of study drug and all radiation therapy (XRT)-associated toxicities resolved to Grade 1 or 0
- History of severe allergic or hypersensitivity reactions to excipients (e.g., Polyethylene glycol [PEG] 300 and Polysorbate 80 [i.e. docetaxel])
- Baseline QTc > 450 msec or previous history of QT prolongation while taking other medications
- Ventricular ejection fraction (Ef) =< 55% at baseline
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- Any history of current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery
- History of current uncontrolled dysrhythmias, or requirement for antiarrhythmic medications, or Grade 2 or greater left bundle branch block
- New York Heart Association class II/III/IV congestive heart failure with a history of dyspnea, orthopnea, or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics
- Current or prior radiation therapy to the left hemithorax
- Treatment with chronic immunosuppressants (e.g. cyclosporine following transplantation)
- Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, 21231
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Medicine nd Denistry of New Jersey
Piscataway, New Jersey, 08854
University of Wisconsin Cancer Center Riverview
Wisconsin Rapids, Wisconsin, 54494
About this study
Official title: A Phase II Trial of STA-9090 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Based Chemotherapy
Hsp90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. This phase II trial is studying how well Hsp90 inhibitor STA-9090 works in treating patients with metastatic hormone-resistant prostate cancer previously treated with docetaxel-based chemotherapy
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate progression-free survival (PFS) achieved with STA-9090 (Hsp90 inhibitor STA-9090) in men with castration-resistant prostate cancer (CRPC) who have received prior docetaxel based therapy.
SECONDARY OBJECTIVES:
- To assess the percentage change in prostate-specific antigen (PSA) from baseline to 12 weeks.
II. To assess overall safety and tolerability of STA-9090. III. To evaluate overall survival (OS) outcome in metastatic CRPC who have received prior docetaxel therapy.
IV. To investigate the association of progression-free survival (PFS) and PSA response rate with primary and secondary target markers.
TERTIARY OBJECTIVES:
- To evaluate potential markers for predicting drug response or efficacy, blood samples will be used to collect the serum and extract messenger ribonucleic acid (mRNA) from mononuclear cells and analyzed by quantitative real-time polymerase chain reaction (PCR) and/or enzyme-linked immunosorbent assay (ELISA).
OUTLINE:
Patients receive Hsp90 inhibitor STA-9090 intravenously (IV) over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks.
- Conditions
- Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer
- Being tested
- Hsp90 inhibitor STA-9090, laboratory biomarker analysis, polymerase chain reaction, enzyme-linked immunosorbent assay, RNA analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hsp90 inhibitor STA-9090Drug
Also called STA-9090
Given IV
laboratory biomarker analysisOther
Correlative studies
polymerase chain reactionGenetic
Also called PCR
Correlative studies
enzyme-linked immunosorbent assayOther
Also called ELISA
Correlative studies
RNA analysisGenetic
Correlative studies
spectrophotometryOther
Correlative studies
reverse transcriptase-polymerase chain reactionGenetic
Also called RT-PCR
Correlative studies
gene expression analysisGenetic
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (enzyme inhibitor therapy) | Experimental | Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: Hsp90 inhibitor STA-9090; Other: laboratory biomarker analysis; Genetic: polymerase chain reaction; Other: enzyme-linked immunosorbent assay; Genetic: RNA analysis; Other: spectrophotometry; Genetic: reverse transcriptase-polymerase chain reaction; Genetic: gene expression analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy
Our primary objective was to determine the 6-month PFS rate by using a binary (yes/no) endpoint of 6 months of PFS. Treatment success was defined as achievement of at least 6 months of PFS. Patients who did not complete 6 months of ganetespib therapy for any reason (including death from any cause) were considered treatment failures and were recorded as not achieving the primary endpoint.
Measured: At 6 months
Secondary outcomes (5)
Percentage Change in PSA
Percentage change in PSA from baseline.
Measured: From baseline to 12 weeks
Overall Safety and Tolerability of STA-9090
Overall safety and tolerability of STA-9090 by total number of grade 3 adverse events
Measured: Day 1, 8, and 15 of each course and at end of treatment
OS in Metastatic CRPC Who Have Received Prior Docetaxel Therapy
Overall Survival (OS) in metastatic Castrate Resistant Prostate Cancer (CRPC) who have received prior docetaxel therapy using Kaplan-Meier method
Measured: From first dose to death or the date last known alive
Association of PFS With PSA
Association of PFS with PSA using Cox PH regression model
Measured: At 6 months
Potential Markers for Predicting Drug Response or Efficacy
Potential markers for predicting drug response or efficacy : This is not a measurable outcome, but a possible entity for further study.
Measured: At baseline, day 1 of course 3, and end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenocarcinoma of the ProstateStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Elisabeth Heath, Barbara Ann Karmanos Cancer Institute
- Investigators
- Elisabeth Heath, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270880
- Sponsor's protocol ID
- 2010-070
- Other IDs
- NCI-2010-02328
- Status last verified
- Feb 2018
- First submitted
- 4 Jan 2011
- Last updated
- 18 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of STA-9090 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Based Chemotherapy
- ClinicalTrials.gov ID
- NCT01270880
- Acronym / sponsor ID
- 2010-070
- Conditions
- Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Posted 14 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hsp90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. This phase II trial is studying how well Hsp90 inhibitor STA-9090 works in treating patients with metastatic hormone-resistant prostate cancer previously treated with docetaxel-based chemotherapy
Detailed description
PRIMARY OBJECTIVES:
- To evaluate progression-free survival (PFS) achieved with STA-9090 (Hsp90 inhibitor STA-9090) in men with castration-resistant prostate cancer (CRPC) who have received prior docetaxel based therapy.
SECONDARY OBJECTIVES:
- To assess the percentage change in prostate-specific antigen (PSA) from baseline to 12 weeks.
II. To assess overall safety and tolerability of STA-9090. III. To evaluate overall survival (OS) outcome in metastatic CRPC who have received prior docetaxel therapy.
IV. To investigate the association of progression-free survival (PFS) and PSA response rate with primary and secondary target markers.
TERTIARY OBJECTIVES:
- To evaluate potential markers for predicting drug response or efficacy, blood samples will be used to collect the serum and extract messenger ribonucleic acid (mRNA) from mononuclear cells and analyzed by quantitative real-time polymerase chain reaction (PCR) and/or enzyme-linked immunosorbent assay (ELISA).
OUTLINE:
Patients receive Hsp90 inhibitor STA-9090 intravenously (IV) over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (enzyme inhibitor therapy) | Experimental | Drug: Hsp90 inhibitor STA-9090, Other: laboratory biomarker analysis, Genetic: polymerase chain reaction, Other: enzyme-linked immunosorbent assay, Genetic: RNA analysis, Other: spectrophotometry, Genetic: reverse transcriptase-polymerase chain reaction, Genetic: gene expression analysisPatients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Pathologically confirmed diagnosis of prostate adenocarcinoma with metastasis and objective progression or rising PSA despite androgen deprivation therapy and antiandrogen withdrawal when applicable
- Progression after docetaxel based chemotherapy is needed as follows:
- a) If measurable disease present, then either rising PSA, increase in size of the lesion/s or both should be present
- b) Patients with rising PSA only as progression must demonstrate a rising trend with 2 successive elevations at minimum intervals of 1 week; a minimum PSA of 5 ng/ml, or new areas of bony metastases on bone scan are required for patients with no measurable disease; no minimum PSA requirement for patients with measurable disease
- Patients should have received at least one prior docetaxel based regimen for metastatic disease; no maximum prior therapy
Key exclusion criteria (13 listed)
- Major surgery within 4 weeks prior to first dose of STA-9090
- Poor venous access for study drug administration or would require a peripheral or central indwelling catheter for study drug administration; study drug administration via indwelling catheters is prohibited at this time
- Use of any chemotherapy or other standard systemic treatments for prostate cancer, including investigational agents within 2 weeks or 6 half- lives of the agent, whichever is shorter, prior to receiving STA-9090; there must be at least 2 weeks between the end of palliative radiation and the start of study drug and all radiation therapy (XRT)-associated toxicities resolved to Grade 1 or 0
- History of severe allergic or hypersensitivity reactions to excipients (e.g., Polyethylene glycol [PEG] 300 and Polysorbate 80 [i.e. docetaxel])
- Baseline QTc > 450 msec or previous history of QT prolongation while taking other medications
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 |
|---|---|---|
| Hsp90 inhibitor STA-9090Also: STA-9090Given IV | Drug | Treatment (enzyme inhibitor therapy) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (enzyme inhibitor therapy) |
| polymerase chain reactionAlso: PCRCorrelative studies | Genetic | Treatment (enzyme inhibitor therapy) |
| enzyme-linked immunosorbent assayAlso: ELISACorrelative studies | Other | Treatment (enzyme inhibitor therapy) |
| RNA analysisCorrelative studies | Genetic | Treatment (enzyme inhibitor therapy) |
| spectrophotometryCorrelative studies | Other | Treatment (enzyme inhibitor therapy) |
| reverse transcriptase-polymerase chain reactionAlso: RT-PCRCorrelative studies | Genetic | Treatment (enzyme inhibitor therapy) |
| gene expression analysisCorrelative studies | Genetic | Treatment (enzyme inhibitor therapy) |
Primary outcome
PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy
Time frame: At 6 months
Our primary objective was to determine the 6-month PFS rate by using a binary (yes/no) endpoint of 6 months of PFS. Treatment success was defined as achievement of at least 6 months of PFS. Patients who did not complete 6 months of ganetespib therapy for any reason (including death from any cause) were considered treatment failures and were recorded as not achieving the primary endpoint.
5 secondary outcomes
Percentage Change in PSA
Time frame: From baseline to 12 weeks
Overall Safety and Tolerability of STA-9090
Time frame: Day 1, 8, and 15 of each course and at end of treatment
OS in Metastatic CRPC Who Have Received Prior Docetaxel Therapy
Time frame: From first dose to death or the date last known alive
Association of PFS With PSA
Time frame: At 6 months
Potential Markers for Predicting Drug Response or Efficacy
Time frame: At baseline, day 1 of course 3, and end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elisabeth Heath principal investigator
Barbara Ann Karmanos Cancer Institute
4 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 Hsp90 inhibitor STA-9090, laboratory biomarker analysis and polymerase chain reaction in people with Adenocarcinoma of the Prostate and Hormone-resistant Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 4 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 19 inclusion and 13 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 18 Sep 2018. 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 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?
Yes. Results are posted in the registry (first posted 14 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy (time frame: At 6 months). 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 18 Sep 2018.