Safety, Preliminary Efficacy and Pharmacokinetics of ASN001 in Metastatic Castrate Resistant Prostate Cancer

Stopped early · Phase 1

Conditions studied: Cancer of the Prostate, Neoplasms, Prostate, Prostate Cancer, Prostatic Cancer, Neoplasms, Prostatic, Prostate Neoplasms, Castration-resistant

In brief

This study will be conducted in three parts. Part A is a dose-escalation study to determine two safe and tolerable doses of ASN001 for men with metastatic castration resistant prostate cancer. Part A will also characterize the pharmacokinetics and pharmacodynamics of the ASN001 through blood sampling. Subjects in Part B will receive one of two doses identified in Part A to determine which one is more effective, and collect additional pharmacokinetic data. Part C is an extension for subjects completing either Part A or B.

Key facts

Study ID

NCT02349139

Run by

Asana BioSciences

People needed

27

Starts

2015-01-19

Expected to finish

2017-08-17

Last updated by the study team

2018-03-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed adenocarcinoma of the prostate.
• Ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, or bilateral orchiectomy and serum testosterone level < 50 ng/dL (< 0.5 ng/mL, < 1.7 nmol/L) at screening
• Metastatic disease documented by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan.
• Progressive disease despite ongoing androgen deprivation therapy.
• Adequate liver, kidney, and bone marrow function
• Life expectancy of at least 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening
• Patients with prior cytotoxic chemotherapy are eligible to participate if they have been progression free for at least 12 months since the initiation of cytotoxic chemotherapy

You may not qualify if…

• Patients with rapidly progressive disease who are candidates for other approved therapies such as docetaxel, abiraterone, and enzalutamide.
• Prior therapy with abiraterone, orteronel, ketoconazole, or any other Cytochrome P450 (CYP) 17 lyase inhibitor; enzalutamide or other experimental androgen receptor antagonist; or experimental immunotherapy agent.
• History of impaired adrenal gland function
• Any investigational treatments for any condition within 4 weeks prior to the start of study treatment.
• Therapy with herbal products known to effect PSA, or estrogen within 30 days prior to the start of study medication
• Known gastrointestinal disease or condition that affects the absorption of ASN001, or difficulty swallowing large capsules.
• Use of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication
• Major surgery within 30 days of study medication
• Known brain metastasis
• Previous history of another cancer within 5 years, except completely removed basal or squamous cell skin cancer.
• Serious concurrent medical conditions including: serious heart disease, heart conduction abnormalities, persistent infection, uncontrolled psychiatric illness, liver cirrhosis, chronic liver disease, active or symptomatic viral hepatitis, any other condition that may place the subject at an increased risk or confound the results of the study.

Where it is running

• UCLA Medical Center, Clark Urology Center — Los Angeles, California, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Abramson Cancer Center, Hospital of the Univ. of Pennsylvania — Philadelphia, Pennsylvania, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
• University of Virginia Cancer Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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