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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
BIND Therapeutics
ClinicalTrials.gov Identifier:
NCT01812746
First received: March 14, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
CRPC
Prostate Cancer
Drug: BIND-014
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by BIND Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Number of patients with a progression-free survival of 6 months


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Number of patients who experience adverse events


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIND-014 Drug: BIND-014

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812746

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

Publications:
Responsible Party: BIND Therapeutics
ClinicalTrials.gov Identifier: NCT01812746     History of Changes
Other Study ID Numbers: BIND-014-004
Study First Received: March 14, 2013
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014