A Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy to Patients With Non-Small Cell Lung Cancer
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).
Checked against the public recordLast updated Apr 15, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- BIND Therapeutics
- Interventions being studied
- Drug: BIND-014
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Investigative Site #10Goodyear, Arizona
- Investigative Site #04Los Angeles, California
- Investigative Site #02Fort Meyers, Florida
- Investigative Site #08Newnan, Georgia
- Investigative Site #07Zion, Illinois
- Investigative Site #03Columbus, Ohio
- Investigative Site #09Tulsa, Oklahoma
- Investigative Site #11Philadelphia, Pennsylvania
- Investigative Site #05Pittsburgh, Pennsylvania
- Investigative Site #01Nashville, Tennessee
- Investigative Site #15Chelyabinsk
- Site #17Krasnodar
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 15, 2016. Always confirm current availability with the study team.