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

Phase 1

Terminated

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

• Registration Number: NCT02349139
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-01-13
• Study Start: 2015-01-19
• Study First Submitted QC: 2015-01-23
• Study First Posted: 2015-01-28
• Primary Completion: 2017-07-14
• Study Completion: 2017-08-17
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Determine the maximum tolerated dose (MTD) of ASN001	First 28 days	The MTD will be determined by evaluating the number of subjects with treatment related dose limiting toxicity.

Secondary Outcome Measures

Name	Time	Method
Calculate the pharmacokinetic profile of ASN001	First 29 days	Pharmacokinetic Parameters
Change in tumor size by CT, MRI or bone scan	12 weeks	measure of efficacy
Time on treatment	52 weeks	Measure of safety, tolerability and preliminary efficacy
Change in ECOG performance status (score 0 to 5) from baseline as assessed by the investigator	12 weeks	Measure of efficacy

Trial Locations

Locations (6)

University of Virginia Cancer Center; 🇺🇸 Charlottesville, Virginia, United States

UCLA Medical Center, Clark Urology Center; 🇺🇸 Los Angeles, California, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States

Abramson Cancer Center, Hospital of the Univ. of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States