Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC, lung cancer
Brief summary
The purpose of this study is to evaluate the efficacy and safety of BIND-014 in patients with advanced non-small cell lung cancer (NSCLC).
Interventions
DRUGBIND-014
Sponsors
BIND Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females at least 18 years of age * Diagnosis of NSCLC with locally advanced or metastatic disease * Previously treated with one platinum-based chemotherapy * Disease status must be that of measurable and/or evaluable disease * Performance status of 0 to 1 on the ECOG Scale * Prior chemotherapy completed at least 3 weeks prior to study enrollment * Prior radiation therapy allowed to \< 25% of the bone marrow * Patient compliance and geographic proximity that allow adequate follow-up * Adequate organ function * Patients with reproductive potential must use contraceptive methods * Signed informed consent from patient
Exclusion criteria
* Active infection * Pregnancy or planning to become pregnant * Breast feeding * Serious concomitant systemic disorders * Second primary malignancy * Patients who are symptomatic from brain metastasis * Presence of detectable (by physical exam) third-space fluid collections * More than 1 prior cytotoxic chemotherapy regimen for advanced disease * Prior treatment with docetaxel * History of severe hypersensitivity reaction to polysorbate 80 * Peripheral neuropathy at study entry * Patients known to be HIV positive * Patients known to be seropositive for hepatitis C hepatitis B * Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with either a complete or partial response | Patients will be followed for the duration of treatment, an expected average of 18 weeks | To determine the efficacy of BIND-014 as measured by objective response rate (ORR) in patients with Stage III/IV Non-small cell lung cancer (NSCLC) who have failed one prior platinum containing chemotherapy regimen for advanced or metastatic disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who experience adverse events | Patients will be followed for the duration of treatment, an expected average of 18 weeks | To assess the safety and tolerability of BIND-014 |
Countries
Russia, United States
Outcome results
None listed