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

NCT02349139 | Terminated Phase 1

• 1 other identifier: ASN001-101
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 6

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.

Conditions

Cancer of the Prostate; Neoplasms, Prostate; Prostate Cancer; Prostatic Cancer; Neoplasms, Prostatic; Prostate Neoplasms, Castration-resistant

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose (MTD) of ASN001

  The MTD will be determined by evaluating the number of subjects with treatment related dose limiting toxicity.

  First 28 days

Secondary Outcomes (4)

• Calculate the pharmacokinetic profile of ASN001

  First 29 days

• Change in tumor size by CT, MRI or bone scan

  12 weeks

• Change in ECOG performance status (score 0 to 5) from baseline as assessed by the investigator

  12 weeks

• Time on treatment

  52 weeks

Other Outcomes (2)

• Concentration of serum bone-specific alkaline phosphatase (BAP)

  12 weeks

• The effect of ASN001 on steroid biosynthesis

  52 weeks

Study Arms (1)

ASN001: Escalating dose Part A

EXPERIMENTAL

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

Interventions

ASN001: Escalating dose Part A DRUG

Androgen inhibitor

ASN001: Escalating dose Part A

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.
• 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.

Sponsors & Collaborators

• Asana BioSciences: lead

Study Sites (6)

UCLA Medical Center, Clark Urology Center

Los Angeles, California, 90095, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Abramson Cancer Center, Hospital of the Univ. of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Niranjan Rao, PhD

  Asana BioSciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 28, 2015
• Study Start: January 19, 2015
• Primary Completion: July 14, 2017
• Study Completion: August 17, 2017
• Last Updated: March 7, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)