Clinical Trial: NCT02283320 - My Cancer Genome

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

URL:

https://clinicaltrials.gov/show/NCT02283320

Trial Eligibility

Document

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

ORG STUDY ID: BIND-014-007
NCT ID: NCT02283320

Conditions

KRAS Positive Patients With Non-small Cell Lung Cancer
Squamous Cell Non-small Cell Lung Cancer

Interventions

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

Purpose

Trial Arms

Name	Type	Description	Interventions
BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)	Experimental		BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Disease control rate
Time Frame:	Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Progression-free survival
Time Frame:	Change in tumor size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average of 18 weeks.
Safety Issue:
Description:

Measure:	Overall survival
Time Frame:	Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
Safety Issue:
Description:

Measure:	Duration of response
Time Frame:	Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks
Safety Issue:
Description:

Measure:	Time to response
Time Frame:	change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 relative to first dose of study drug
Safety Issue:
Description:

Measure:	Disease control rate
Time Frame:	Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks
Safety Issue:
Description:

Measure:	Safety and tolerability, as measured by number of participants with adverse events.
Time Frame:	Measured from first dose of study drug until 30 days after study discontinuation.
Safety Issue:
Description:

Measure:	Objective response rate
Time Frame:	change in tumour size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected 12 weeks,
Safety Issue:
Description:

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Completed
Lead Sponsor:	BIND Therapeutics

Last Updated

April 18, 2016

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