Clinical Trials /

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

NCT02283320

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

A Study of BIND-014 (<span class="go-doc-concept go-doc-intervention">Docetaxel</span> Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With <span class="go-doc-concept go-doc-biomarker">KRAS</span> Positive or Squamous Cell Non-Small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span>

Title

  • Brief Title: 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
  • Official Title: An Open Label, Multicenter, Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as a Second-Line Therapy for Patients With KRAS Mutation Positive or Squamous Cell Non-Small Cell Lung Cancer
  • Clinical Trial IDs

    NCT ID: NCT02283320

    ORG ID: BIND-014-007

    Trial Conditions

    KRAS Positive Patients With Non-small Cell Lung Cancer

    Squamous Cell Non-small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions

    Eligibility 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Disease control rate

    Secondary Outcome Measures

    Progression-free survival

    Overall survival

    Duration of response

    Time to response

    Disease control rate

    Safety and tolerability, as measured by number of participants with adverse events.

    Objective response rate

    Trial Keywords