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

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
Sponsor:
Information provided by (Responsible Party):
BIND Therapeutics

Tracking Information
First Submitted Date  ICMJE February 17, 2011
First Posted Date  ICMJE February 21, 2011
Last Update Posted Date February 9, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
To assess the dose limiting toxicities (DLTs) of BIND-014 when given once every three weeks. [ Time Frame: 18 months ]
This information will be used to determine the maximum tolerated dose (MTD) of BIND-014 when given once every three weeks and to select a dose or doses of BIND-014 for use in Phase 2 clinical studies.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
  • To characterize the pharmacokinetics of BIND-014 following an IV infusion. [ Time Frame: First two doses 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of BIND-014 Given to Patients With Advanced or Metastatic Cancer
Official Title  ICMJE 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
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Cancer
  • Cancer
  • Solid Tumors
Intervention  ICMJE Drug: BIND-014
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2016)
58
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion 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.

Exclusion 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01300533
Other Study ID Numbers  ICMJE BIND-014-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://clincancerres.aacrjournals.org/content/early/2016/02/04/1078-0432.CCR-15-2548.full.pdf+html
Responsible Party BIND Therapeutics
Study Sponsor  ICMJE BIND Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BIND Therapeutics
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP