Status:
COMPLETED
A Study of BIO-11006 in the Treatment of Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
BioMarck Pharmaceuticals, Ltd.
Conditions:
Non Small Cell Lung Cancer Stage IIIB
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This Phase 2 is a randomized study in advanced Non-Small Cell lung cancer patients to evaluate safety and efficacy of aerosolized BIO-11006 in conjunction with chemotherapy.
Detailed Description
This randomized, open label, multicenter Phase 2 study is to evaluate safety and efficacy of BIO-11006 in Stage IIIB Non Small Cell Lung cancer (NSCLC) patients who are not candidates for curative sur...
Eligibility Criteria
Inclusion
- Patients who are physically able to self administer drug by nebulizer;
- Measurable disease per RECIST Version 1.1;
- Female patients of child bearing age must have a negative pregnancy test;
- ECOG 0-2;
- Written informed consent;
Exclusion
- Candidates for curative surgery and/or radiation therapy;
- Baseline ANC\<2000 cells/mm cube; platelet count \<100,000 cells/mm cube
- Creatinine clearance \<45 mL/min;
- Billirubin \>2 x the upper limit of normal
- Known history of HIV, hepatitis B, hepatitis C or tuberculosis;
- Current pneumonia or idiopathic pulmonary fibrosis;
- Hypersensitivity to test drug, pemetrexed, or carboplatin.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03472053
Start Date
February 1 2018
End Date
December 30 2019
Last Update
May 19 2020
Active Locations (11)
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1
Unique Hospital and Research Institute
Surat, Gujarat, India, 395002
2
Aadhar Health Institute
Hisar, Haryana, India, 125005
3
Chirayu Cancer Hospital
Bhopal, Madhya Pradesh, India, 462030
4
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012