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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Asana BioSciences
Sponsor:
Information provided by (Responsible Party):
Asana BioSciences
ClinicalTrials.gov Identifier:
NCT02349139
First received: January 13, 2015
Last updated: February 2, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Cancer of the Prostate
Neoplasms, Prostate
Prostate Cancer
Prostatic Cancer
Neoplasms, Prostatic
Prostate Neoplasms, Castration-resistant
Drug: ASN001: Escalating dose Part A
Drug: ASN001: Dose 1 Part B
Drug: ASN001: Dose 2 Part B
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Asana BioSciences:

Primary Outcome Measures:
  • 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.

  • Change from baseline in Prostate-Specific Antigen (PSA) levels [ Time Frame: 12 weeks ]

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

  • Change in tumor size by CT, MRI or bone scan [ Time Frame: 12 weeks ]
  • Change in ECOG performance status (score 0 to 5) from baseline as assessed by the investigator [ Time Frame: 12 weeks ]
  • Time on treatment [ Time Frame: 52 weeks ]

Other Outcome Measures:
  • 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)

  • 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


Estimated Enrollment: 116
Study Start Date: January 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: ASN001: Dose 1 Part B
Subjects will be assigned to one of two doses from Part A of the study to determine the best dose for further development.
Drug: ASN001: Dose 1 Part B
Androgen inhibitor
Drug: ASN001: Dose 2 Part B
Androgen inhibitor
Experimental: ASN001:Dose 2 Part B
Subjects will be assigned to one of two doses from Part A of the study to determine the best dose for further development..
Drug: ASN001: Dose 1 Part B
Androgen inhibitor
Drug: ASN001: Dose 2 Part B
Androgen inhibitor

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.

  Eligibility

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

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.
  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: NCT02349139

Contacts
Contact: Penny Bristow, MS 908-698-4973 penny.bristow@asanabio.com

Locations
United States, California
UCLA Medical Center, Clark Urology Center Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Allan J Pantuck, M.D.         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Ulka Vaishampayan, M.D.         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Jorge Garcia, M.D.         
United States, Pennsylvania
Abramson Cancer Center, Hospital of the Univ. of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Naomi Haas, M.D.         
United States, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Anthony Tolcherr, M.D.         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Principal Investigator: Robert Dreicer, M.D.         
Sponsors and Collaborators
Asana BioSciences
Investigators
Study Director: Niranjan Rao, PhD Asana BioSciences
  More Information

Additional Information:
Responsible Party: Asana BioSciences
ClinicalTrials.gov Identifier: NCT02349139     History of Changes
Other Study ID Numbers: ASN001-101
Study First Received: January 13, 2015
Last Updated: February 2, 2017
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on March 27, 2017