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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| ClinicalTrials.gov Identifier: NCT01792479 |
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Recruitment Status :
Completed
First Posted : February 15, 2013
Last Update Posted : April 15, 2016
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Sponsor:
BIND Therapeutics
Information provided by (Responsible Party):
BIND Therapeutics
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-small Cell Lung Cancer | Drug: BIND-014 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 64 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | April 2013 |
| Actual Primary Completion Date : | April 2016 |
| Actual Study Completion Date : | April 2016 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Docetaxel
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm A: BIND-014 every 3 weeks |
Drug: BIND-014 |
| Experimental: Arm B: BIND-014 weekly |
Drug: BIND-014 |
Primary Outcome Measures :
- Number of patients with either a complete or partial response [ Time Frame: 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 :
- Number of patients who experience adverse events [ Time Frame: Patients will be followed for the duration of treatment, an expected average of 18 weeks ]To assess the safety and tolerability of BIND-014
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792479
Locations
| United States, Arizona | |
| Investigative Site #10 | |
| Goodyear, Arizona, United States, 85338 | |
| United States, California | |
| Investigative Site #04 | |
| Los Angeles, California, United States, 90048 | |
| United States, Florida | |
| Investigative Site #02 | |
| Fort Meyers, Florida, United States, 33905 | |
| United States, Georgia | |
| Investigative Site #08 | |
| Newnan, Georgia, United States, 30265 | |
| United States, Illinois | |
| Investigative Site #07 | |
| Zion, Illinois, United States, 60099 | |
| United States, Ohio | |
| Investigative Site #03 | |
| Columbus, Ohio, United States, 43221 | |
| United States, Oklahoma | |
| Investigative Site #09 | |
| Tulsa, Oklahoma, United States, 74133 | |
| United States, Pennsylvania | |
| Investigative Site #11 | |
| Philadelphia, Pennsylvania, United States, 19124 | |
| Investigative Site #05 | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Tennessee | |
| Investigative Site #01 | |
| Nashville, Tennessee, United States, 37203 | |
| Russian Federation | |
| Investigative Site #15 | |
| Chelyabinsk, Russian Federation, 454087 | |
| Site #17 | |
| Krasnodar, Russian Federation | |
| Investigative Site #12 | |
| Moscow, Russian Federation, 115478 | |
| Site # 18 | |
| Saint Petersburg, Russian Federation | |
| Investigative Site #14 | |
| Saint-Petersberg, Russian Federation, 198255 | |
| Investigative Site #13 | |
| Saint-Petersberg, Russian Federation, 97758 | |
| Investigative Site #16 | |
| Ufa, Russian Federation, 450054 | |
Sponsors and Collaborators
BIND Therapeutics
Publications:
| Responsible Party: | BIND Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01792479 History of Changes |
| Other Study ID Numbers: |
BIND-014-005 |
| First Posted: | February 15, 2013 Key Record Dates |
| Last Update Posted: | April 15, 2016 |
| Last Verified: | April 2016 |
Keywords provided by BIND Therapeutics:
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NSCLC lung cancer |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |