A 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
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIND-014
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring NSCLC, lung cancer
Eligibility Criteria
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
Sites / Locations
- Investigative Site #10
- Investigative Site #04
- Investigative Site #02
- Investigative Site #08
- Investigative Site #07
- Investigative Site #03
- Investigative Site #09
- Investigative Site #11
- Investigative Site #05
- Investigative Site #01
- Investigative Site #15
- Site #17
- Investigative Site #12
- Site # 18
- Investigative Site #14
- Investigative Site #13
- Investigative Site #16
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A: BIND-014 every 3 weeks
Arm B: BIND-014 weekly
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with either a complete or partial response
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.
Secondary Outcome Measures
Number of patients who experience adverse events
To assess the safety and tolerability of BIND-014
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01792479
Brief Title
A 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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BIND Therapeutics
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of BIND-014 in patients with advanced non-small cell lung cancer (NSCLC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
NSCLC, lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: BIND-014 every 3 weeks
Arm Type
Experimental
Arm Title
Arm B: BIND-014 weekly
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BIND-014
Primary Outcome Measure Information:
Title
Number of patients with either a complete or partial response
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.
Time Frame
Patients will be followed for the duration of treatment, an expected average of 18 weeks
Secondary Outcome Measure Information:
Title
Number of patients who experience adverse events
Description
To assess the safety and tolerability of BIND-014
Time Frame
Patients will be followed for the duration of treatment, an expected average of 18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Investigative Site #10
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
Investigative Site #04
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Investigative Site #02
City
Fort Meyers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
Facility Name
Investigative Site #08
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Investigative Site #07
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Investigative Site #03
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Investigative Site #09
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Investigative Site #11
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Investigative Site #05
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Investigative Site #01
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Investigative Site #15
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Site #17
City
Krasnodar
Country
Russian Federation
Facility Name
Investigative Site #12
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Site # 18
City
Saint Petersburg
Country
Russian Federation
Facility Name
Investigative Site #14
City
Saint-Petersberg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Investigative Site #13
City
Saint-Petersberg
ZIP/Postal Code
97758
Country
Russian Federation
Facility Name
Investigative Site #16
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
22491949
Citation
Hrkach J, Von Hoff D, Mukkaram Ali M, Andrianova E, Auer J, Campbell T, De Witt D, Figa M, Figueiredo M, Horhota A, Low S, McDonnell K, Peeke E, Retnarajan B, Sabnis A, Schnipper E, Song JJ, Song YH, Summa J, Tompsett D, Troiano G, Van Geen Hoven T, Wright J, LoRusso P, Kantoff PW, Bander NH, Sweeney C, Farokhzad OC, Langer R, Zale S. Preclinical development and clinical translation of a PSMA-targeted docetaxel nanoparticle with a differentiated pharmacological profile. Sci Transl Med. 2012 Apr 4;4(128):128ra39. doi: 10.1126/scitranslmed.3003651.
Results Reference
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A 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
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