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

• Sponsor: BIND Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01812746
• Collaborator: (none)
• Enrollment: 42
• Locations: 8
• Arm: 1
• Duration (Months): 36
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
CRPC; Prostate Cancer	Drug: BIND-014	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2013
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BIND-014	Drug: BIND-014

Outcome Measures

Primary Outcome Measures

1. To determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve metastatic CRPC [Patients will be followed for the duration of treatment, an expected average of 24 weeks]

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

Secondary Outcome Measures

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]

   Number of patients who experience adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site #16	Los Angeles	California	United States	90048
2	Investigative Site #14	San Francisco	California	United States	94115
3	Investigative Site #17	Fort Meyers	Florida	United States	33908
4	Investigational Site #12	Ann Arbor	Michigan	United States	48109
5	Investigational Site #11	New York	New York	United States	10065
6	Investigational Site #15	Chapel Hill	North Carolina	United States	27514
7	Investigational Site #13	Cleveland	Ohio	United States	44195
8	Investigational Site #18	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• BIND Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: BIND Therapeutics
• ClinicalTrials.gov Identifier: NCT01812746
• Other Study ID Numbers: BIND-014-004
• First Posted: Mar 18, 2013
• Last Update Posted: Apr 15, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Apr 15, 2016