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A Phase II Trial of STA-9090 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Based Chemotherapy

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer

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Trial Information

A Phase II Trial of STA-9090 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Based Chemotherapy


I. 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.


I. To assess the percentage change in prostate-specific antigen (PSA) from baseline to 12

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.


I. 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).


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.

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

- 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

- 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

Exclusion Criteria:

- 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

- 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

- Current or prior radiation therapy to the left hemithorax

- Treatment with chronic immunosuppressants (e.g. cyclosporine following

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS proportion achieved with STA-9090 in men with CRPC who have received prior docetaxel based therapy

Outcome Description:

Defined as the time from first dose until the patient demonstrates disease progression based on PSA changes, discontinues STA-9090 therapy (for any reason), or expires (from any cause), whichever occurs first. Estimated with the standard Kaplan-Meier (K-M) method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived.

Outcome Time Frame:

At 6 months

Safety Issue:


Principal Investigator

Elisabeth Heath

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karmanos Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



Karmanos Cancer Institute Detroit, Michigan  48201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital Baltimore, Maryland  21231
University of Wisconsin Cancer Center Riverview Wisconsin Rapids, Wisconsin  54494
University of Medicine nd Denistry of New Jersey Piscataway, New Jersey  08854