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
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.
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.