A Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension), Administered to Patients With Metastatic Castration-Resistant Prostate Cancer

April 14, 2016 updated by: BIND Therapeutics

An Open Label, Multicenter, Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension), Administered to Patients With Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to evaluate the efficacy and safety BIND-014 in patients with metastatic castration-resistant prostate cancer (mCRPC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Investigative Site #16
      • San Francisco, California, United States, 94115
        • Investigative Site #14
    • Florida
      • Fort Meyers, Florida, United States, 33908
        • Investigative Site #17
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Investigational Site #12
    • New York
      • New York, New York, United States, 10065
        • Investigational Site #11
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Investigational Site #15
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Investigational Site #13
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Investigational Site #18

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Metastatic disease progressing despite castrate levels of testosterone
  • Prostate cancer progression documented by PSA
  • Surgically or medically castrated, with testosterone levels of < 50 ng/dL
  • Previous anti-androgen therapy and progression after withdrawal
  • ECOG performance status of 0 to 1
  • Adequate organ function
  • Prior radiation therapy allowed to < 25% of the bone marrow
  • Prior hormonal therapy is allowed
  • Patient compliance and geographic proximity that allow adequate follow-up.
  • Patients with reproductive potential must use contraceptive methods
  • Signed informed consent from patient

Exclusion Criteria:

  • Active infection
  • Any chronic medical condition requiring a high doses of corticosteroid
  • Pathological finding consistent with small cell carcinoma of the prostate
  • Brain metastasis
  • Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
  • Radiation therapy for treatment of the primary tumor within 6 weeks
  • Radionuclide therapy for treatment of metastatic CRPC
  • Prior systemic treatment with an azole drug
  • Prior flutamide treatment within 4 weeks
  • Prior bicalutamide or nilutamide within 6 weeks
  • Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia
  • Administration of an investigational therapeutic within 2 weeks
  • Second primary malignancy
  • Presence of clinically detectable third-space fluid collections
  • History of severe hypersensitivity reaction to polysorbate 80
  • Peripheral neuropathy at study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BIND-014
Drug: BIND-014

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve metastatic CRPC
Time Frame: Patients will be followed for the duration of treatment, an expected average of 24 weeks
Number of patients with a progression-free survival of 6 months
Patients will be followed for the duration of treatment, an expected average of 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the safety and tolerability of BIND-014
Time Frame: Patients will be followed for the duration of treatment, an expected average of 24 weeks
Number of patients who experience adverse events
Patients will be followed for the duration of treatment, an expected average of 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BIND Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (ESTIMATE)

March 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIND-014-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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