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Phase I/II, Multi-center, Open Label, Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of ASP9521 in Patients With Metastatic Castrate-resistant Prostate Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Castrate Resistant Prostate Cancer

Thank you

Trial Information

Phase I/II, Multi-center, Open Label, Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of ASP9521 in Patients With Metastatic Castrate-resistant Prostate Cancer

The purpose of the first study part is to investigate the safety and tolerability of ASP9521
in patients with Castrate Resistant Prostate Cancer. This will be done at different doses,
starting at the lowest dose up to higher doses to find the maximum dose that is tolerated.

The second part will investigate the safety and tolerability and evaluate initial anti-tumor
activity of ASP9521. This will be done at multiple doses which are identified in part 1 to
potentially be effective. The number of patients in part 2 will be higher number compared to
part I.

The third part of the study will investigate the effect of food on the drug in patients;
this will be a crossover design fed to fasted and vice versa.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine
differentiation or small cell features

- Metastatic disease documented by 2 or more bone lesions on bone scan or by soft
tissue disease observed by Computed tomography/Magnetic resonance imaging (CT/MRI)

- Ongoing androgen deprivation with Luteinizing hormone-releasing hormone (LHRH)
agonist/antagonist therapy or bilateral orchiectomy. For patients who have not had an
orchiectomy, there must be a plan to maintain effective LHRH agonist/antagonist
therapy for the duration of the study

- Serum testosterone <1.7 nmol/L (50 ng/dL) at screening

- Patients receiving bisphosphonates or other approved bone targeting therapy must have
been on stable doses for at least 4 weeks prior to screening

- Progressive disease at study entry defined as one or more of the following 3 criteria
occurring in the setting of castrate levels of testosterone:

- Prostate-specific antigen (PSA) progression defined by a minimum of 2 rising PSA
levels with an interval of >1 week between each determination. The PSA value at
screening should be >2 ng/mL

- Soft tissue disease progression defined by Response Evaluation Criteria in Solid
Tumors (RECIST). Measurable disease is not required for entry. Lymph nodes >20
mm are considered measurable disease

- Bone disease progression defined by at least 2 new lesions on bone scan

- Life expectancy of >6 months according to the investigator's judgment

- Chemotherapy-Naïve patients should be asymptomatic or controlled symptomatic patients
with metastatic CRPC who have failed one or more lines of hormonal treatment/androgen
deprivation therapy but have not received chemotherapy or have refused chemotherapy.
Post chemotherapy patients should have received not more than two prior regimens of
chemotherapy for prostate cancer, of which one is docetaxel-based

Exclusion Criteria:

- Concomitant treatment with the following is prohibited:

- All biologic agents (except for sipuleucel T [Provenge®]), or other agents with
anti-tumor activity against prostate cancer, including 5 alpha reductase
inhibitors, androgens (e.g., testosterone), cytoproterone acetate and all other
progestational agents, estrogens, and flutamide within 4 weeks prior to

- Bicalutamide or nilutamide within 6 weeks prior to screening

- Treatment with estramustine

- Ketoconazole for treatment of prostate cancer

- Treatment with abiraterone

- Radiation therapy for treatment of the prostate within 3 months prior to screening

- Radiation therapy for the treatment of metastases within 3 weeks (if single fraction
of radiotherapy then within 2 weeks) and radionuclide therapy for the treatment of
metastases within 4 weeks prior to screening

- Major surgery within 2 months prior to screening

- Known or suspected intracerebral disease or brain metastasis

- Use of an investigational agent within 4 weeks prior to treatment allocation or a
period required by local regulation, whichever is longer

- Prior use, or participation in a clinical study, of an investigational agent that
blocks androgen synthesis or targets the androgen receptor

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the safety and tolerability, based on the frequency and severity of Adverse Events (AEs), laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations

Outcome Time Frame:

Up to day 28 and further

Safety Issue:


Principal Investigator

Use Central Contact

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Europe BV


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

March 2011

Completion Date:

September 2012

Related Keywords:

  • Castrate Resistant Prostate Cancer
  • ASP9521
  • Castrate Resistant Prostate Cancer
  • Phase 1/2
  • Prostatic Neoplasms