Phase 2
N=18
Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Adenocarcinoma of the Prostate · Hormone-resistant Prostate Cancer · Recurrent Prostate Cancer · Stage IV Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01270880 ↗Enrolled (actual)
18
Serious AEs
55.6%
Results posted
Apr 2015
Primary outcome: Primary: PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy — 0.0 proportion with 6+ months PFS
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hsp90 inhibitor STA-9090 (Drug); laboratory biomarker analysis (Other); polymerase chain reaction (Genetic); enzyme-linked immunosorbent assay (Other); RNA analysis (Genetic); spectrophotometry (Other); reverse transcriptase-polymerase chain reaction (Genetic); gene expression analysis (Genetic)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Barbara Ann Karmanos Cancer Institute
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy |
0.0 | — |
| SECONDARY Percentage Change in PSA |
78.65 | — |
| SECONDARY Overall Safety and Tolerability of STA-9090 |
35 | — |
| SECONDARY OS in Metastatic CRPC Who Have Received Prior Docetaxel Therapy |
12.5 | — |
| SECONDARY Association of PFS With PSA |
1.000 | — |
| SECONDARY Potential Markers for Predicting Drug Response or Efficacy |
— | — |
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
Eligibility Criteria
Inclusion Criteria
- 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
- 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 = = 1,500 cells/uL
- Platelets >= 100,000/uL
- Hemoglobin >= 9.0 g/dL
- Serum creatinine = 1.5 x ULN, subject is eligible if the calculated creatinine clearance (CLcr) is >= 50 mL/min
- Total bilirubin = 450 msec or previous history of QT prolongation while taking other medications
- Ventricular ejection fraction (Ef) =< 55% at baseline
- 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
Data sourced from ClinicalTrials.gov (NCT01270880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.