Trials / Terminated

TerminatedNCT02349139

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

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

Status: Terminated
Phase: Phase 1
Study type: Interventional
Enrollment: 27 (actual)

Sponsor: Asana BioSciences · Industry
Sex: Male
Age: 18 Years
Healthy volunteers: Not accepted

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)

Conditions

Interventions

Type	Name	Description
DRUG	ASN001: Escalating dose Part A	Androgen inhibitor

Timeline

Start date: 2015-01-19
Primary completion: 2017-07-14
Completion: 2017-08-17
First posted: 2015-01-28
Last updated: 2018-03-07

Locations

6 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02349139. Inclusion in this directory is not an endorsement.