CompletedPhase 1NCT01300533
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBIND-014

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 9, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?BIND Therapeutics

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
BIND Therapeutics
Interventions being studied
Drug: BIND-014
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 1. Signed informed consent form. (ICF) 2. At least 18 years old. 3. Patients with histologically or cytologically confirmed advanced or metastatic cancer for which no standard or curative therapy exists. 4. Measurable or evaluable disease per RECIST version 1.1. 5. Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1. 6. Life expectancy of greater than 12 weeks. 7. Female subjects are eligible to enter and participate in the study if they are of: 1. 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). 2. 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.
Reasons someone may not be able to joinExclusion criteria

1. 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. 2. 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). 3. Serum bilirubin \> 1.2 times the upper limit of normal (ULN). 4. An alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level \> 1.5 x ULN with alkaline phosphatase \> 2.5 x ULN. 5. Serum creatinine \> 1.5 x ULN or a creatinine clearance of \< 50 mL/min calculated by Cockcroft-Gault. 6. Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac \[including life-threatening arrhythmias\], hepatic, or renal disease). 7. 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. 8. 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. 9. Participation in a study of an investigational agent within 30 days prior to screening. 10. Having received treatment for their cancer (including chemotherapy, surgery and/or radiation) within the 30 days prior to screening. 11. Pregnant or breast-feeding females. 12. 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 13. Peritoneal or pleural effusions requiring a tap more frequently than every 14 days. 14. 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Investigational Site #01Scottsdale, Arizona
  • Investigational Site #02Greenbrae, California
  • Investigational Site #04Los Angeles, California
  • Investigational Site #06Fort Meyers, Florida
  • Investigational Site #03Detriot, Michigan
  • Investigational Site #05Nashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 9, 2016. Always confirm current availability with the study team.

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