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

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: NCT02349139
Recruitment Status : Terminated (Business Decision)
First Posted : January 28, 2015
Last Update Posted : March 7, 2018
Information provided by (Responsible Party):
Asana BioSciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer of the Prostate Neoplasms, Prostate Prostate Cancer Prostatic Cancer Neoplasms, Prostatic Prostate Neoplasms, Castration-resistant Drug: ASN001: Escalating dose Part A Phase 1

Detailed Description:

Parts A and B will include a screening period (up to 28 days) and a 12-week treatment period. A subject with no serious adverse drug reactions and who is expected to benefit from continued treatment in the opinion of the investigator will have the opportunity to participate in the long-term extension (Part C). If the subject is not a candidate for or chooses not to participate in the long-term extension (Part C), a post-treatment period of 4 weeks will commence that concludes with an end-of-study visit.

Subjects participating in only Part A or Part B will have approximately 9 study site visits over 18 weeks. Part C will include monthly visits to the study site for 9 months. Thereafter, visits will occur every 3 months. A subject with stable disease or response may continue ASN001 treatment with the approval of the investigator; treatment can continue until a subject experiences an intolerable adverse event (AE) or disease progression, withdraws consent or until termination of the study by the sponsor. At the end of treatment, a post-treatment period of 4 weeks will commence that concludes with an end-of-study visit.

Part B of the study will not be completed as enrollment was halted after Part A (Phase 1)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Uncontrolled, Multiple-Dose Escalation, Cohort Expansion And Extension Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of ASN001 In Subjects With Metastatic Progressive Castrate Resistant Prostate Cancer
Actual Study Start Date : January 19, 2015
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : August 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Asparagine

Arm Intervention/treatment
Experimental: ASN001: Escalating dose Part A
The dose of ASN001 will be based on the assigned study group. The initial dose level of ASN001 will be 50 mg daily. After a safety review, the dose may be escalated for the next group of subjects. Additional dose levels are 100 mg, 200 mg, 300 mg, and 400 mg.
Drug: ASN001: Escalating dose Part A
Androgen inhibitor

Primary Outcome Measures :
  1. Determine the maximum tolerated dose (MTD) of ASN001 [ Time Frame: First 28 days ]
    The MTD will be determined by evaluating the number of subjects with treatment related dose limiting toxicity.

Secondary Outcome Measures :
  1. Calculate the pharmacokinetic profile of ASN001 [ Time Frame: First 29 days ]
    Pharmacokinetic Parameters

  2. Change in tumor size by CT, MRI or bone scan [ Time Frame: 12 weeks ]
    measure of efficacy

  3. Change in ECOG performance status (score 0 to 5) from baseline as assessed by the investigator [ Time Frame: 12 weeks ]
    Measure of efficacy

  4. Time on treatment [ Time Frame: 52 weeks ]
    Measure of safety, tolerability and preliminary efficacy

Other Outcome Measures:
  1. Concentration of serum bone-specific alkaline phosphatase (BAP) [ Time Frame: 12 weeks ]
    To evaluate the effects of ASN001 on the concentration of serum bone-specific alkaline phosphatase (BAP)

  2. The effect of ASN001 on steroid biosynthesis [ Time Frame: 52 weeks ]
    Effects on Luteinizing hormone, follicle stimulating hormone, cortisol, adrenocorticotropic hormone, deoxycorticosterone, corticosterone, dehydroepiandrosterone (DHEA), DHEA sulfate, testosterone and dihydrotestosterone

Information from the National Library of Medicine

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

Inclusion Criteria

  • 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

Exclusion Criteria:

  • 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.

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): NCT02349139

United States, California
UCLA Medical Center, Clark Urology Center
Los Angeles, California, United States, 90095
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center, Hospital of the Univ. of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Asana BioSciences
Study Director: Niranjan Rao, PhD Asana BioSciences

Responsible Party: Asana BioSciences Identifier: NCT02349139     History of Changes
Other Study ID Numbers: ASN001-101
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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