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Metastatic CancerPhase 1NCT01300533

A Study of BIND-014 Given to Patients With Advanced or Metastatic Cancer

A Phase 1 study testing BIND-014 in people with Metastatic Cancer and Cancer, run by BIND Therapeutics at 6 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 goal of this Phase 1 clinical research study is to find the highest safe dose of BIND-014 that can be given in the treatment of patients with advanced or metastatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Cancer, Cancer, Solid Tumors
What is being tested?
BIND-014
How many people
58 participants
Where
6 sitesUnited States
Study dates
Jan 2011to Feb 2016
Phase
Phase 1
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent form. (ICF)
  • At least 18 years old.
  • Patients with histologically or cytologically confirmed advanced or metastatic cancer for which no standard or curative therapy exists.
  • Measurable or evaluable disease per RECIST version 1.1.
  • Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1.
  • Life expectancy of greater than 12 weeks.
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  • Female subjects are eligible to enter and participate in the study if they are of:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who:
  • Has had a hysterectomy, or
  • Has had a bilateral oophorectomy (ovariectomy), or
  • Has had a bilateral tubal ligation, or
  • Is post-menopausal (demonstrated total cessation of menses for at least 1 year).
  • Childbearing (CB) potential, as long as they have a negative serum pregnancy test at screening and at follow-up, and agrees to one of the following:
  • Use an intrauterine device (IUD) with a documented failure rate of less than 1% per year.
  • Use double barrier contraception method defined as condom with spermicidal jelly, foam, suppository, or film; OR diaphragm with spermicide; OR male condom and diaphragm.
  • The woman's sole male sexual partner is a vasectomized male who is sterile prior to the subject's entry into this study.

Who cannot join

  • Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before entry, and stable without steroid treatment for at least 4 weeks.
  • Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count (ANC) < 1.5 x 10^9/L or platelet count < 100 x 10^9/L (cannot be post-transfusion) or hemoglobin < 9 g/dL (can be post-transfusion).
  • Serum bilirubin > 1.2 times the upper limit of normal (ULN).
  • An alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 1.5 x ULN with alkaline phosphatase > 2.5 x ULN.
  • Serum creatinine > 1.5 x ULN or a creatinine clearance of < 50 mL/min calculated by Cockcroft-Gault.
  • Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac [including life-threatening arrhythmias], hepatic, or renal disease).
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  • Unresolved toxicity ≥ Common Toxicity Criteria (CTC) grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the Medical Monitor.
  • QTc prolongation defined as a QTc with Framingham correction greater than or equal to 470 ms or a prior history of arrhythmias or significant electrocardiogram (ECG) abnormalities. Certain conditions are acceptable (e.g., controlled atrial fibrillation) if agreed to by Medical Monitor.
  • Participation in a study of an investigational agent within 30 days prior to screening.
  • Having received treatment for their cancer (including chemotherapy, surgery and/or radiation) within the 30 days prior to screening.
  • Pregnant or breast-feeding females.
  • Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
  • Peritoneal or pleural effusions requiring a tap more frequently than every 14 days.
  • Any concurrent condition which, in the Investigator's opinion, makes it undesirable for the subject to participate in this study or which would jeopardize compliance with the protocol.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Investigational Site #03

    Detriot, Michigan, 48201

  • Investigational Site #06

    Fort Meyers, Florida, 33905

  • Investigational Site #02

    Greenbrae, California, 94904

  • Investigational Site #04

    Los Angeles, California, 90048

  • Investigational Site #05

    Nashville, Tennessee, 37203

  • Investigational Site #01

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase 1 Open Label, Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension), Given by Intravenous Infusion to Patients With Advanced or Metastatic Cancer

The goal of this Phase 1 clinical research study is to find the highest safe dose of BIND-014 that can be given in the treatment of patients with advanced or metastatic cancer.

Read the detailed description

The study is designed to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of BIND-014 and define a recommended Phase 2 dose of BIND-014.

All cycles of therapy will consist of the patient taking BIND-014 intravenously once every three weeks or weekly for three out of four weeks.

Being tested
BIND-014
Keywords
Cancer, Neoplasms, Solid Tumor, Ovarian Cancer, Lung Cancer, Non-Small Cell Lung Cancer, Pancreatic Cancer, Breast Cancer, Endometrial Cancer, Melanoma, Prostate Cancer, Skin Cancer, Head and Neck Cancer, Solid Malignancies
Medical subject headings
Neoplasm Metastasis, Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Breast Neoplasms, Endometrial Neoplasms

What participants receive

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

  • BIND-014Drug

What is being measured

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

  1. To assess the dose limiting toxicities (DLTs) of BIND-014 when on day 1 of a 21-day cycle or when given on day 1, 8 and 15 of a 28-day cycle.

    This information will be used to determine the maximum tolerated dose (MTD) of BIND-014 when given weekly or three weeks.

Secondary outcomes (3)

  1. To characterize the pharmacokinetics of BIND-014 following an IV infusion.

    Pharmacokinetic parameters such as time to peak concentration (Tmax), peak concentration (Cmax), minimum concentration (Cmin), volume of distribution (Vd), half life (t1/2), total body clearance (CL) and area under the concentration-time curve (AUC) will be determined for each patient using plasma concentration data.

    Measured: First two cycles of BIND-014

  2. To assess any preliminary evidence of anti-tumor activity observed with BIND-014.

    Measured: 18 months

  3. To assess changes in serum tumor markers when appropriate.

    Measured: 18 months

Timeline

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

  1. First posted21 Feb 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionSep 2013
  4. Study completionFeb 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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01300533
Sponsor's protocol ID
BIND-014-001
Status last verified
Feb 2016
First submitted
17 Feb 2011
Last updated
9 Feb 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: http://clincancerres.aacrjournals.org/content/early/2016/02/04/1078-0432.CCR-15-2548.full.pdf+html

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIND-014 in people with Metastatic Cancer and Cancer, run by BIND Therapeutics at 6 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 16 inclusion and 14 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 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 assess the dose limiting toxicities (DLTs) of BIND-014 when on day 1 of a 21-day cycle or when given on day 1, 8 and 15 of a 28-day cycle.. 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 NCT01300533.

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 9 Feb 2016.

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