A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer
BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.
Checked against the public recordLast updated Apr 18, 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 (Docetaxel Nanoparticles for Injectable Suspension)
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 * Positive for KRAS mutation or Squamous cell histology * 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: #51Chandler, Arizona
- Investigative Site: #30Goodyear, Arizona
- Investigative Site: #44Phoenix, Arizona
- Investigative Site: #41Sedona, Arizona
- Investigative Site: #58Duarte, California
- Investigative Site: #47La Jolla, California
- Investigative Site: #32Los Angeles, California
- Investigative Site: #50San Francisco, California
- Investigative Site: #46Fort Meyers, Florida
- Investigative Site: #53Newnan, Georgia
- Investigative Site: #56Savannah, Georgia
- Investigative Site: #35Zion, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 18, 2016. Always confirm current availability with the study team.