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

This study has been terminated.
(It was decided to discontinue the development in consideration of the results of a P1 study)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01352208
First received: April 14, 2011
Last updated: March 21, 2014
Last verified: December 2012
  Purpose

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 Intervention Phase
Castrate Resistant Prostate Cancer
Drug: ASP9521
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Decline in Prostate-specific antigen (PSA) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: March 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP9521 Drug: ASP9521
oral

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352208

Locations
Belgium
Site 131
Antwerp, Belgium, 2650
France
Site: 121
Villejuif, France
United Kingdom
Site:109
Glasgow, United Kingdom
Site: 101
Surrey, United Kingdom
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01352208     History of Changes
Other Study ID Numbers: 9521-CL-0002, 2010-023382-22
Study First Received: April 14, 2011
Last Updated: March 21, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
ASP9521
Castrate Resistant Prostate Cancer
Phase 1/2

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

ClinicalTrials.gov processed this record on August 21, 2014