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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

Primary Purpose

CRPC, Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BIND-014
Sponsored by
BIND Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CRPC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Investigative Site #16
  • Investigative Site #14
  • Investigative Site #17
  • Investigational Site #12
  • Investigational Site #11
  • Investigational Site #15
  • Investigational Site #13
  • Investigational Site #18

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIND-014

Arm Description

Outcomes

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
Number of patients with a progression-free survival of 6 months

Secondary Outcome Measures

To assess the safety and tolerability of BIND-014
Number of patients who experience adverse events

Full Information

First Posted
March 14, 2013
Last Updated
April 14, 2016
Sponsor
BIND Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01812746
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BIND Therapeutics

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CRPC, Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIND-014
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BIND-014
Primary Outcome Measure Information:
Title
To determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve metastatic CRPC
Description
Number of patients with a progression-free survival of 6 months
Time Frame
Patients will be followed for the duration of treatment, an expected average of 24 weeks
Secondary Outcome Measure Information:
Title
To assess the safety and tolerability of BIND-014
Description
Number of patients who experience adverse events
Time Frame
Patients will be followed for the duration of treatment, an expected average of 24 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Investigative Site #16
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Investigative Site #14
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Investigative Site #17
City
Fort Meyers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Investigational Site #12
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Investigational Site #11
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Investigational Site #15
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Investigational Site #13
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Investigational Site #18
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22491949
Citation
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.
Results Reference
background
PubMed Identifier
29978216
Citation
Autio KA, Dreicer R, Anderson J, Garcia JA, Alva A, Hart LL, Milowsky MI, Posadas EM, Ryan CJ, Graf RP, Dittamore R, Schreiber NA, Summa JM, Youssoufian H, Morris MJ, Scher HI. Safety and Efficacy of BIND-014, a Docetaxel Nanoparticle Targeting Prostate-Specific Membrane Antigen for Patients With Metastatic Castration-Resistant Prostate Cancer: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Oct 1;4(10):1344-1351. doi: 10.1001/jamaoncol.2018.2168.
Results Reference
derived

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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

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