A Study of BIO-11006 in the Treatment of Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03472053

Recruitment Status : Active, not recruiting

First Posted : March 21, 2018

Last Update Posted : March 14, 2019

Sponsor:

Information provided by (Responsible Party):

BioMarck Pharmaceuticals, Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Cancer Stage IIIB	Drug: BIO-11006 plus standard of care Drug: Standard of Care	Phase 2

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 surgery, radiation, or immunotherapy and who are also receiving Pemetrexed and Carboplatin as standard of care (SOC). This study will be conducted at ten clinical centers in India under an IND from US-FDA and an IND from Indian FDA.

This is a parallel 2- Arm study in which a total of 60 patients will be randomized. One Arm of 30 subjects will receive aerosolized 125mg BIO-11006 BID using Pari eFlow nebulizer in conjunction with SOC chemotherapy (Pemetrexed plus Carboplatin). A second Arm of 30 subjects will receive only SOC chemotherapy (Pemetrexed plus Carboplatin). The treatment period will be three months and nine months survival follow up period (every three months).

Primary efficacy endpoint will be Progression-free survival (PFS) in patients who receive BIO-11006 plus SOC compared to those who receive SOC alone. The secondary efficacy endpoints will include: a. Response rate at three months (4 cycles) per RECIST V1.1; (b) overall survival; and (c) patient body weight maintenance.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Patients will be randomized in 1:1 ratio to either BIO-11006 plus Standard of Care (intervention) or Standard of Care (Pemetrexed plus Carboplatin) (intervention).
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Study of the Safety and Efficacy of BIO-11006 in Treatment of Advanced Non-Small Cell Lung Cancer in Patients Who Are Not Candidates for Curative Surgery and/or Radiation and Who Are Receiving Pemetrexed and Carboplatin
Actual Study Start Date :	February 1, 2018
Estimated Primary Completion Date :	November 30, 2019
Estimated Study Completion Date :	December 30, 2019

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: Carboplatin Pemetrexed

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: BIO-11006 plus standard of care Aerosolized BIO-11006 (125mg BID) plus standard of care (Pemetrexed plus Carboplatin) is administered for three months.	Drug: BIO-11006 plus standard of care BIO-11006 is administered 125mg BID plus standard of care. Other Name: Active drug plus standard of care
Experimental: Standard of Care Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's Formula) is administered every three weeks for three months.	Drug: Standard of Care Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's formula) are administered every three weeks for three months. Other Name: Active comparator

Outcome Measures

Primary Outcome Measures :

Progression-free survival [ Time Frame: 12 months ]
Survival period of patients in both arms of the study is measured in absence of tumor progression.

Secondary Outcome Measures :

Maintenance of body weight [ Time Frame: 3 and12 months ]
Patient's body weight in kilograms measured at three month and at 12 month to assess possible disease related cachexia.
Treatment emergent adverse effects [ Time Frame: 3 months ]
Treatment-emergent adverse events including headache, bronchitis, dyspnea, cough, pyrexia, chest discomfort and liver function will be evaluated.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

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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): NCT03472053

Locations

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India
Vardhman Mahavir Medical College & Hospital
New Delhi, Delhi, India, 110029
Unique Hospital and Research Institute
Surat, Gujarat, India, 395002
Aadhar Health Institute
Hisar, Hariyana, India, 125005
HCG Manavata Cancer Center
Nashik, Maharashtra, India, 422004
Deenanath Mangeshkar Hospital & Research Center
Pune, Maharashtra, India, 411004
Tata Memorial Hospital
Mumbai, Maharastra, India, 400012
Navsanjeevani Hospital
Nashik, Maharastra, India, 422002
Chirayu Cancer Hospital
Bhopal, MP, India, 462030
Sparsh Hospitals and Critical Care
Bhubaneswar, Odisa, India, 751007
SMS Medical College & Hospital
Jaipur, Rajasthan, India, 302016
Nehru Hospital & Post Graduate Institute of Medical Education
Chandigarh, India, 160012

Sponsors and Collaborators

BioMarck Pharmaceuticals, Ltd.

Investigators

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Study Director:	Devesh Verma, PhD	Cliantha Research, India

More Information

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Responsible Party:	BioMarck Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier:	NCT03472053
Other Study ID Numbers:	BIO-NSCLC-001
First Posted:	March 21, 2018 Key Record Dates
Last Update Posted:	March 14, 2019
Last Verified:	December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by BioMarck Pharmaceuticals, Ltd.:


Lung cancer non small cell metastasis

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 Carboplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

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