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Safety and Efficacy Study of KX2-391 for Treatment of Bone-Metastatic, Castration-Resistant Prostate Cancer

NCT01074138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-02-02

No results posted yet for this study

Summary

The standard of care for patients with bone-metastatic, castrate-resistant prostate cancer is chemotherapy. If a patient elects not to choose chemotherapy, 70% will progress within 6 months. KX2-391 given orally twice a day for 6 months will be evaluated for its ability to delay/prevent disease progression in patients who have not had prior chemotherapy.

Conditions

  • Bone-Metastatic, Castration-Resistant Prostate Cancer

Interventions

DRUG

KX2-391

KX2-391 will be administered as a 40 mg oral dosing solution, twice daily, for 6 28-day cycles.

Sponsors & Collaborators

  • Athenex, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Carducci, MD · Johns Hopkins University

  • Min-Fun Rudolf Kwan, MD · Kinex Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-06-30
Completion
2012-10-31

Countries

  • United States

Study Locations

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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 NCT01074138 on ClinicalTrials.gov