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An Open Label, Multicenter, 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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

An Open Label, Multicenter, 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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with either a complete or partial response

Outcome Description:

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.

Outcome Time Frame:

Patients will be followed for the duration of treatment, an expected average of 18 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

BIND-014-005

NCT ID:

NCT01792479

Start Date:

April 2013

Completion Date:

January 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Miami, Florida  33176
Nashville, Tennessee  37203-1632