Phase I/II Study of ASP9521 in Castrate-Resistant Prostate Cancer (CRPC) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01352208
Recruitment Status : Terminated (It was decided to discontinue the development in consideration of the results of a P1 study)
First Posted : May 11, 2011
Last Update Posted : March 24, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The study has three parts. Part 1 is a dose escalation to investigate the safety and tolerability of ASP9521. Part 2 will evaluate the safety and tolerability and initial anti-tumor activity of ASP9521. Part 3 of the study will be a Food Effect study.

Condition or disease Intervention/treatment Phase
Castrate Resistant Prostate Cancer Drug: ASP9521 Phase 1 Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ASP9521 Drug: ASP9521

Primary Outcome Measures :
  1. 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 [ Time Frame: Up to day 28 and further ]

Secondary Outcome Measures :
  1. Decline in Prostate-specific antigen (PSA) [ Time Frame: Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 screening
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01352208

Site 131
Antwerp, Belgium, 2650
Site: 121
Villejuif, France
United Kingdom
Glasgow, United Kingdom
Site: 101
Surrey, United Kingdom
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma Europe B.V.

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc Identifier: NCT01352208     History of Changes
Other Study ID Numbers: 9521-CL-0002
2010-023382-22 ( EudraCT Number )
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: December 2012

Keywords provided by Astellas Pharma Inc:
Castrate Resistant Prostate Cancer
Phase 1/2

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases