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

NCT01352208 | Terminated Phase 1

• 2 other identifiers: 9521-CL-00022010-023382-22
• Study Type: interventional
• Target: 13
• Locations: 3 countries
• Sites: 4

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.

Conditions

Castrate Resistant Prostate Cancer

Keywords

ASP9521; Castrate Resistant Prostate Cancer; Phase 1/2

Outcome Measures

Primary Outcomes (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

  Up to day 28 and further

Secondary Outcomes (1)

• Decline in Prostate-specific antigen (PSA)

  Week 12

Study Arms (1)

ASP9521

EXPERIMENTAL

Drug: ASP9521

Interventions

ASP9521 DRUG

oral

ASP9521

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (4)

Site 131

Antwerp, 2650, Belgium

Location

Site: 121

Villejuif, France

Location

Site:109

Glasgow, United Kingdom

Location

Site: 101

Surrey, United Kingdom

Location

Related Publications (1)

• Loriot Y, Fizazi K, Jones RJ, Van den Brande J, Molife RL, Omlin A, James ND, Baskin-Bey E, Heeringa M, Baron B, Holtkamp GM, Ouatas T, De Bono JS. Safety, tolerability and anti-tumour activity of the androgen biosynthesis inhibitor ASP9521 in patients with metastatic castration-resistant prostate cancer: multi-centre phase I/II study. Invest New Drugs. 2014 Oct;32(5):995-1004. doi: 10.1007/s10637-014-0101-x. Epub 2014 Apr 27.

  PMID: 24771350 DERIVED

MeSH Terms

Interventions

1-(1-((5-methoxy-1H-indol-2-yl)carbonyl)piperidin-4-yl)-2-methylpropan-2-ol

Study Officials

• Use Central Contact

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: May 11, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 24, 2014

Record last verified: 2012-12

Locations

GB (2); FR (1); BE (1)