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

NCT02349139 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-03-07

No results posted yet for this study

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

Interventions

DRUG

ASN001: Escalating dose Part A

Androgen inhibitor

Sponsors & Collaborators

  • Asana BioSciences

    lead INDUSTRY

Principal Investigators

  • Niranjan Rao, PhD · Asana BioSciences

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-19
Primary Completion
2017-07-14
Completion
2017-08-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02349139 on ClinicalTrials.gov