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

Squamous Cell Non-small Cell Lung Cancer Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02283320
• Other study ID #: BIND-014-007
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 21, 2014
• Last updated: February 8, 2016
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: February 2016
• Source: BIND Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRussia: Russian Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 69
• Est. completion date: September 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• KRAS Positive Patients With Non-small Cell Lung Cancer
• Lung Neoplasms
• Squamous Cell Non-small Cell Lung Cancer

Intervention

Drug:
• BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

Locations

Country	Name	City	State
Russian Federation	Investigative Site: #74	Archangelsk
Russian Federation	Investigative Site: #75	Istra settle.	Moscow Region
Russian Federation	Investigative Site: #78	Kazan
Russian Federation	Investigative Site: #70	Moscow
Russian Federation	Investigative Site: #79	Rostov-on-Don
Russian Federation	Investigative Site: #71	Saint Petersburg
Russian Federation	Investigative Site: #73	Saint Petersburg
Russian Federation	Investigative Site: #76	Saint Petersburg
Russian Federation	Investigative Site: #77	Saint Petersburg
Russian Federation	Investigative Site: #72	Ufa	Bashkortastan
United States	Investigative Site: #39	Amarillo	Texas
United States	Investigative Site: #40	Blacksburg	Virginia
United States	Investigative Site: #51	Chandler	Arizona
United States	Investigative Site: #42	Dallas	Texas
United States	Investigative Site: 38	Dallas	Texas
United States	Investigative Site: #58	Duarte	California
United States	Investigative Site: #46	Fort Meyers	Florida
United States	Investigative Site: #30	Goodyear	Arizona
United States	Investigative Site: #47	La Jolla	California
United States	Investigative Site: #36	Las Vegas	Nevada
United States	Investigative Site: #32	Los Angeles	California
United States	Investigative Site: #53	Newnan	Georgia
United States	Investigative Site: #44	Phoenix	Arizona
United States	Investigative Site: #34	Pittsburg	Pennsylvania
United States	Investigative Site: # 59	Pittsburgh	Pennsylvania
United States	Investigative Site: #60	Portland	Oregon
United States	Investigative Site: #50	San Francisco	California
United States	Investigative Site: #56	Savannah	Georgia
United States	Investigative Site: #41	Sedona	Arizona
United States	Investigative Site: #45	Vancouver	Washington
United States	Investigative Site: #37	Yakima	Washington
United States	Investigative Site: #35	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
BIND Therapeutics

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control rate		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	No
Secondary	Progression-free survival		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.	No
Secondary	Overall survival		Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation	No
Secondary	Duration of response		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	No
Secondary	Time to response		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	No
Secondary	Disease control rate		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	No
Secondary	Safety and tolerability, as measured by number of participants with adverse events.		Measured from first dose of study drug until 30 days after study discontinuation.	Yes
Secondary	Objective response rate		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,	No