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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

Phase 1
18 Years
Open (Enrolling)
Metastatic Cancer, Cancer, Solid Tumors

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Trial Information

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 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.

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

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

6. Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated
respiratory, cardiac [including life-threatening arrhythmias], hepatic, or renal

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Description:

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

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Cancer
  • Solid Tumors
  • 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
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



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