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

Primary Purpose

Cancer of the Prostate, Neoplasms, Prostate, Prostate Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ASN001: Escalating dose Part A
Sponsored by
Asana BioSciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of the Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA Medical Center, Clark Urology Center
  • Karmanos Cancer Institute
  • Cleveland Clinic Foundation
  • Abramson Cancer Center, Hospital of the Univ. of Pennsylvania
  • South Texas Accelerated Research Therapeutics
  • University of Virginia Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASN001: Escalating dose Part A

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Calculate the pharmacokinetic profile of ASN001
Pharmacokinetic Parameters
Change in tumor size by CT, MRI or bone scan
measure of efficacy
Change in ECOG performance status (score 0 to 5) from baseline as assessed by the investigator
Measure of efficacy
Time on treatment
Measure of safety, tolerability and preliminary efficacy

Full Information

First Posted
January 13, 2015
Last Updated
March 6, 2018
Sponsor
Asana BioSciences
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1. Study Identification

Unique Protocol Identification Number
NCT02349139
Brief Title
Safety, Preliminary Efficacy and Pharmacokinetics of ASN001 in Metastatic Castrate Resistant Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Business Decision
Study Start Date
January 19, 2015 (Actual)
Primary Completion Date
July 14, 2017 (Actual)
Study Completion Date
August 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asana BioSciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Prostate, Neoplasms, Prostate, Prostate Cancer, Prostatic Cancer, Neoplasms, Prostatic, Prostate Neoplasms, Castration-resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASN001: Escalating dose Part A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ASN001: Escalating dose Part A
Intervention Description
Androgen inhibitor
Primary Outcome Measure Information:
Title
Determine the maximum tolerated dose (MTD) of ASN001
Description
The MTD will be determined by evaluating the number of subjects with treatment related dose limiting toxicity.
Time Frame
First 28 days
Secondary Outcome Measure Information:
Title
Calculate the pharmacokinetic profile of ASN001
Description
Pharmacokinetic Parameters
Time Frame
First 29 days
Title
Change in tumor size by CT, MRI or bone scan
Description
measure of efficacy
Time Frame
12 weeks
Title
Change in ECOG performance status (score 0 to 5) from baseline as assessed by the investigator
Description
Measure of efficacy
Time Frame
12 weeks
Title
Time on treatment
Description
Measure of safety, tolerability and preliminary efficacy
Time Frame
52 weeks
Other Pre-specified Outcome Measures:
Title
Concentration of serum bone-specific alkaline phosphatase (BAP)
Description
To evaluate the effects of ASN001 on the concentration of serum bone-specific alkaline phosphatase (BAP)
Time Frame
12 weeks
Title
The effect of ASN001 on steroid biosynthesis
Description
Effects on Luteinizing hormone, follicle stimulating hormone, cortisol, adrenocorticotropic hormone, deoxycorticosterone, corticosterone, dehydroepiandrosterone (DHEA), DHEA sulfate, testosterone and dihydrotestosterone
Time Frame
52 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niranjan Rao, PhD
Organizational Affiliation
Asana BioSciences
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Medical Center, Clark Urology Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Abramson Cancer Center, Hospital of the Univ. of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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