Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-01 @ 8:56 PM
Study NCT ID:
NCT02283320
Status:
COMPLETED
Last Update Posted:
2016-04-18
First Post:
2014-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-14', 'studyFirstSubmitDate': '2014-10-21', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease control rate', 'timeFrame': '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'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '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.'}, {'measure': 'Overall survival', 'timeFrame': 'Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation'}, {'measure': 'Duration of response', 'timeFrame': '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'}, {'measure': 'Time to response', 'timeFrame': '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'}, {'measure': 'Disease control rate', 'timeFrame': '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'}, {'measure': 'Safety and tolerability, as measured by number of participants with adverse events.', 'timeFrame': 'Measured from first dose of study drug until 30 days after study discontinuation.'}, {'measure': 'Objective response rate', 'timeFrame': '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,'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['KRAS Positive Patients With Non-small Cell Lung Cancer', 'Squamous Cell Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females at least 18 years of age\n* Diagnosis of NSCLC with locally advanced or metastatic disease\n* Positive for KRAS mutation or Squamous cell histology\n* Previously treated with one platinum-based chemotherapy\n* Disease status must be that of measurable and/or evaluable disease\n* Performance status of 0 to 1 on the ECOG Scale\n* Prior chemotherapy completed at least 3 weeks prior to study enrollment\n* Prior radiation therapy allowed to \\< 25% of the bone marrow\n* Patient compliance and geographic proximity that allow adequate follow-up\n* Adequate organ function\n* Patients with reproductive potential must use contraceptive methods\n* Signed informed consent from patient\n\nExclusion Criteria:\n\n* Active infection\n* Pregnancy or planning to become pregnant\n* Breast feeding\n* Serious concomitant systemic disorders\n* Second primary malignancy\n* Patients who are symptomatic from brain metastasis\n* Presence of detectable (by physical exam) third-space fluid collections\n* More than 1 prior cytotoxic chemotherapy regimen for advanced disease\n* Prior treatment with docetaxel\n* History of severe hypersensitivity reaction to polysorbate 80\n* Peripheral neuropathy at study entry\n* Patients known to be HIV positive\n* Patients known to be seropositive for hepatitis C hepatitis B\n* Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia'}, 'identificationModule': {'nctId': 'NCT02283320', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'BIND Therapeutics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BIND-014-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)', 'interventionNames': ['Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)']}], 'interventions': [{'name': 'BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)', 'type': 'DRUG', 'armGroupLabels': ['BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site: #51', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85338', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site: #30', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site: #44', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '86336', 'city': 'Sedona', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site: #41', 'geoPoint': {'lat': 34.86974, 'lon': -111.76099}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site: #58', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site: #47', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site: #32', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site: #50', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33916', 'city': 'Fort Meyers', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigative Site: #46'}, {'zip': '30265', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigative Site: #53', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigative Site: #56', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60099', 'city': 'Zion', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigative Site: #35', 'geoPoint': {'lat': 42.44613, 'lon': -87.83285}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigative Site: #36', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigative Site: #60', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigative Site: #34', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15240', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigative Site: # 59', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigative Site: #39', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigative Site: #42', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75237', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigative Site: 38', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '24060', 'city': 'Blacksburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigative Site: #40', 'geoPoint': {'lat': 37.22957, 'lon': -80.41394}}, {'zip': '98684', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Investigative Site: #45', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}, {'zip': '98902', 'city': 'Yakima', 'state': 'Washington', 'country': 'United States', 'facility': 'Investigative Site: #37', 'geoPoint': {'lat': 46.60207, 'lon': -120.5059}}, {'zip': '450054', 'city': 'Ufa', 'state': 'Bashkortastan', 'country': 'Russia', 'facility': 'Investigative Site: #72', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '143423', 'city': 'Istra Settle.', 'state': 'Moscow Oblast', 'country': 'Russia', 'facility': 'Investigative Site: #75'}, {'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Investigative Site: #74', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '420029', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Investigative Site: #78', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '115478', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Investigative Site: #70', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603024', 'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Investigative Site: #79', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Investigative Site: #76', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197758', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Investigative Site: #71', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197758', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Investigative Site: #73', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '198255', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Investigative Site: #77', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BIND Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}