A Study of BIND-014 Given to Patients With Advanced or Metastatic Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01300533 |
Recruitment Status :
Completed
First Posted : February 21, 2011
Last Update Posted : February 9, 2016
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Cancer Cancer Solid Tumors | Drug: BIND-014 | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 58 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | February 2016 |

- 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.
- To characterize the pharmacokinetics of BIND-014 following an IV infusion. [ Time Frame: First two cycles of BIND-014 ]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.
- To assess any preliminary evidence of anti-tumor activity observed with BIND-014. [ Time Frame: 18 months ]
- To assess changes in serum tumor markers when appropriate. [ Time Frame: 18 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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:
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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).
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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.
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Exclusion Criteria:
- 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).
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300533
United States, Arizona | |
Investigational Site #01 | |
Scottsdale, Arizona, United States, 85258 | |
United States, California | |
Investigational Site #02 | |
Greenbrae, California, United States, 94904 | |
Investigational Site #04 | |
Los Angeles, California, United States, 90048 | |
United States, Florida | |
Investigational Site #06 | |
Fort Meyers, Florida, United States, 33905 | |
United States, Michigan | |
Investigational Site #03 | |
Detriot, Michigan, United States, 48201 | |
United States, Tennessee | |
Investigational Site #05 | |
Nashville, Tennessee, United States, 37203 |
Responsible Party: | BIND Therapeutics |
ClinicalTrials.gov Identifier: | NCT01300533 |
Other Study ID Numbers: |
BIND-014-001 |
First Posted: | February 21, 2011 Key Record Dates |
Last Update Posted: | February 9, 2016 |
Last Verified: | February 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | http://clincancerres.aacrjournals.org/content/early/2016/02/04/1078-0432.CCR-15-2548.full.pdf+html |
Cancer Neoplasms Solid Tumor Ovarian Cancer Lung Cancer Non-Small Cell Lung Cancer Pancreatic Cancer |
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Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |