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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BIND Therapeutics
• Treatments: Docetaxel

Criteria

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