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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
BIND Therapeutics
ClinicalTrials.gov Identifier:
NCT01300533
First received: February 17, 2011
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Cancer
Solid Tumors
Drug: BIND-014
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by BIND Therapeutics:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: Yes ]
    This information will be used to determine the maximum tolerated dose (MTD) of BIND-014 when given weekly or three weeks.


Secondary Outcome Measures:
  • To characterize the pharmacokinetics of BIND-014 following an IV infusion. [ Time Frame: First two cycles of BIND-014 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • To assess changes in serum tumor markers when appropriate. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2011
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300533

Locations
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
Sponsors and Collaborators
BIND Therapeutics
  More Information

No publications provided

Responsible Party: BIND Therapeutics
ClinicalTrials.gov Identifier: NCT01300533     History of Changes
Other Study ID Numbers: BIND-014-001
Study First Received: February 17, 2011
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by BIND Therapeutics:
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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014