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

March 14, 2013
February 18, 2014
April 2013
August 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01812746 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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
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).

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • CRPC
  • Prostate Cancer
Drug: BIND-014
Experimental: BIND-014
Intervention: Drug: BIND-014
Hrkach J, Von Hoff D, Mukkaram Ali M, Andrianova E, Auer J, Campbell T, De Witt D, Figa M, Figueiredo M, Horhota A, Low S, McDonnell K, Peeke E, Retnarajan B, Sabnis A, Schnipper E, Song JJ, Song YH, Summa J, Tompsett D, Troiano G, Van Geen Hoven T, Wright J, LoRusso P, Kantoff PW, Bander NH, Sweeney C, Farokhzad OC, Langer R, Zale S. Preclinical development and clinical translation of a PSMA-targeted docetaxel nanoparticle with a differentiated pharmacological profile. Sci Transl Med. 2012 Apr 4;4(128):128ra39. doi: 10.1126/scitranslmed.3003651.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2015
August 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01812746
BIND-014-004
Not Provided
BIND Therapeutics
BIND Therapeutics
Not Provided
Not Provided
BIND Therapeutics
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP