Clinical trial NCT01812746: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: CRPC
Prostate Cancer
Lead sponsor: BIND Therapeutics
Sponsor class: INDUSTRY
First posted: 2013-03-18
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: To determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve metastatic CRPC
timeFrame: Patients will be followed for the duration of treatment, an expected average of 24 weeks
Secondary outcomes:
measure: To assess the safety and tolerability of BIND-014
timeFrame: Patients will be followed for the duration of treatment, an expected average of 24 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Investigative Site #16
state: California
city: San Francisco
country: United States
facility: Investigative Site #14
state: California
city: Fort Meyers
country: United States
facility: Investigative Site #17
state: Florida
city: Ann Arbor
country: United States
facility: Investigational Site #12
state: Michigan
city: New York
country: United States
facility: Investigational Site #11
state: New York
city: Chapel Hill
country: United States
facility: Investigational Site #15
state: North Carolina
city: Cleveland
country: United States
facility: Investigational Site #13
state: Ohio
city: Nashville
country: United States
facility: Investigational Site #18
state: Tennessee
Study officials:
References:
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.
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.