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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812746
• Other study ID #: BIND-014-004
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2013
• Last updated: April 14, 2016
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: BIND Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• CRPC
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• BIND-014

Locations

Country	Name	City	State
United States	Investigational Site #12	Ann Arbor	Michigan
United States	Investigational Site #15	Chapel Hill	North Carolina
United States	Investigational Site #13	Cleveland	Ohio
United States	Investigative Site #17	Fort Meyers	Florida
United States	Investigative Site #16	Los Angeles	California
United States	Investigational Site #18	Nashville	Tennessee
United States	Investigational Site #11	New York	New York
United States	Investigative Site #14	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
BIND Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess the safety and tolerability of BIND-014	Number of patients who experience adverse events	Patients will be followed for the duration of treatment, an expected average of 24 weeks	Yes