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
- Registration Number
- NCT01792479
- Lead Sponsor
- BIND Therapeutics
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A: BIND-014 every 3 weeks BIND-014 - Arm B: BIND-014 weekly BIND-014 -
- Primary Outcome Measures
Name Time Method Number of patients with either a complete or partial response Patients will be followed for the duration of treatment, an expected average of 18 weeks 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
Name Time Method Number of patients who experience adverse events Patients will be followed for the duration of treatment, an expected average of 18 weeks To assess the safety and tolerability of BIND-014
Trial Locations
- Locations (17)
Investigative Site #08
🇺🇸Newnan, Georgia, United States
Site #17
🇷🇺Krasnodar, Russian Federation
Investigative Site #10
🇺🇸Goodyear, Arizona, United States
Investigative Site #07
🇺🇸Zion, Illinois, United States
Investigative Site #02
🇺🇸Fort Meyers, Florida, United States
Investigative Site #12
🇷🇺Moscow, Russian Federation
Investigative Site #03
🇺🇸Columbus, Ohio, United States
Investigative Site #01
🇺🇸Nashville, Tennessee, United States
Investigative Site #11
🇺🇸Philadelphia, Pennsylvania, United States
Investigative Site #16
🇷🇺Ufa, Russian Federation
Investigative Site #04
🇺🇸Los Angeles, California, United States
Investigative Site #09
🇺🇸Tulsa, Oklahoma, United States
Investigative Site #05
🇺🇸Pittsburgh, Pennsylvania, United States
Investigative Site #15
🇷🇺Chelyabinsk, Russian Federation
Site # 18
🇷🇺Saint Petersburg, Russian Federation
Investigative Site #14
🇷🇺Saint-Petersberg, Russian Federation
Investigative Site #13
🇷🇺Saint-Petersberg, Russian Federation