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CRPCPhase 2NCT01812746

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

A Phase 2 study testing BIND-014 in people with CRPC and Prostate Cancer, run by BIND Therapeutics at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
CRPC, Prostate Cancer
What is being tested?
BIND-014
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
8 sitesUnited States
Study dates
Apr 2013to Apr 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Investigational Site #12

    Ann Arbor, Michigan, 48109

  • Investigational Site #15

    Chapel Hill, North Carolina, 27514

  • Investigational Site #13

    Cleveland, Ohio, 44195

  • Investigative Site #17

    Fort Meyers, Florida, 33908

  • Investigative Site #16

    Los Angeles, California, 90048

  • Investigational Site #18

    Nashville, Tennessee, 37203

  • Investigational Site #11

    New York, New York, 10065

  • Investigative Site #14

    San Francisco, California, 94115

Other trials in United States

About this study

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

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

Being tested
BIND-014
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIND-014Drug

Study groups in NCT01812746
Study groupRoleWhat they receive
BIND-014ExperimentalNot described
Receives: Drug: BIND-014

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Patients will be followed for the duration of treatment, an expected average of 24 weeks

Secondary outcomes (1)

  1. To assess the safety and tolerability of BIND-014

    Number of patients who experience adverse events

    Measured: Patients will be followed for the duration of treatment, an expected average of 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01812746
Sponsor's protocol ID
BIND-014-004
Status last verified
Apr 2016
First submitted
14 Mar 2013
Last updated
15 Apr 2016
Results posted
No

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.

    PubMed 22491949

  • 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.

    PubMed 29978216

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIND-014 in people with CRPC and Prostate Cancer, run by BIND Therapeutics at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve metastatic CRPC (time frame: Patients will be followed for the duration of treatment, an expected average of 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01812746, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016; AzTrials last refreshed its copy on 30 Oct 2026.

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