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
1 other identifier
interventional
42
1 country
8
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2013
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2013
CompletedFirst Posted
Study publicly available on registry
March 18, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedApril 15, 2016
April 1, 2016
3 years
March 14, 2013
April 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Patients will be followed for the duration of treatment, an expected average of 24 weeks
Secondary Outcomes (1)
To assess the safety and tolerability of BIND-014
Patients will be followed for the duration of treatment, an expected average of 24 weeks
Study Arms (1)
BIND-014
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Investigative Site #16
Los Angeles, California, 90048, United States
Investigative Site #14
San Francisco, California, 94115, United States
Investigative Site #17
Fort Meyers, Florida, 33908, United States
Investigational Site #12
Ann Arbor, Michigan, 48109, United States
Investigational Site #11
New York, New York, 10065, United States
Investigational Site #15
Chapel Hill, North Carolina, 27514, United States
Investigational Site #13
Cleveland, Ohio, 44195, United States
Investigational Site #18
Nashville, Tennessee, 37203, United States
Related Publications (2)
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.
PMID: 22491949BACKGROUNDAutio 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.
PMID: 29978216DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2013
First Posted
March 18, 2013
Study Start
April 1, 2013
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
April 15, 2016
Record last verified: 2016-04