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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 : Recruiting
First Posted : March 21, 2018
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
BioMarck Pharmaceuticals, Ltd.

Study Description
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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)
Estimated 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 : January 31, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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:

  1. Patients who are physically able to self administer drug by nebulizer;
  2. Measurable disease per RECIST Version 1.1;
  3. Female patients of child bearing age must have a negative pregnancy test;
  4. ECOG 0-2;
  5. Written informed consent;

Exclusion Criteria:

  1. Candidates for curative surgery and/or radiation therapy;
  2. Baseline ANC<2000 cells/mm cube; platelet count <100,000 cells/mm cube
  3. Creatinine clearance <45 mL/min;
  4. Billirubin >2 x the upper limit of normal
  5. Known history of HIV, hepatitis B, hepatitis C or tuberculosis;
  6. Current pneumonia or idiopathic pulmonary fibrosis;
  7. Hypersensitivity to test drug, pemetrexed, or carboplatin.
Contacts and Locations
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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): NCT03472053


Contacts
Contact: Brian Dickson, MD 919-607-8490 bdickson@biomarck.com
Contact: Indu Parikh, PhD 919-593-1274 iparikh@biomarck.com

Locations
India
Vardhman Mahavir Medical College & Hospital Recruiting
New Delhi, Delhi, India, 110029
Contact: Neeraj Singh, MS    +91-880-048-8618    neerajdangwal11@gmail.com   
Principal Investigator: Satya P Kataria, MD         
Sub-Investigator: Kaushal Kalra, MD         
Sub-Investigator: Mukesh Nagar, MD         
Aadhar Health Institute Recruiting
Hisar, Hariyana, India, 125005
Contact: Harish Sharma, MD    +91-989-653-9125    harishsharma72@gmail.com   
Contact: Coordinator    +91-701-819-6594    asankushshm@gmail.com   
Principal Investigator: Lovenish Goyal, MD         
HCG Manavata Cancer Center Recruiting
Nashik, Maharashtra, India, 422004
Contact: Nishtha Paleja, MBBS    +91-982-325-8862    drnishthapaleja@gmail.com   
Principal Investigator: Rajnish Nagarkar, MSBSS         
Sub-Investigator: Vijay Palwe, MD         
Deenanath Mangeshkar Hospital & Research Center Recruiting
Pune, Maharashtra, India, 411004
Contact: A Asmita, BS    +91-996-008-4830    asmitaharne2412@gmail.com   
Principal Investigator: Chetan Deshmukh, MD         
Sub-Investigator: Padmaj Kulkarni, MD         
Tata Memorial Hospital Recruiting
Mumbai, Maharastra, India, 400012
Contact: Vijay Patil, MD    +91-986-938-2266    vijaypgi@gmail.com   
Contact: Coordinator    +91-983-394-4571    drsrushti25@gmail.com   
Principal Investigator: Amit Joshi, MD         
Sub-Investigator: Kumar Prabhash, MD         
Chirayu Cancer Hospital Recruiting
Bhopal, MP, India, 462030
Contact: Hakimudin Malvi, MD    +91-942-567-2336    hakimmalvi@yahoo.co.in   
Principal Investigator: Tarini P Sahoo, MD         
Sparsh Hospitals and Critical Care Recruiting
Bhubaneswar, Odisa, India, 751007
Contact: Siddharth Mohanty, MS    +91-732-707-8993    sidharthmohanty74@gmail.com   
Principal Investigator: Ghanashyam Biswas, MD         
Sub-Investigator: Bharat Das, MD         
SMS Medical College & Hospital Recruiting
Jaipur, Rajasthan, India, 302016
Contact: Shivraj Sharma, MD    +91-141-400-7619    drsrs74@gmail.com   
Contact: Coordinator    +91-756-823-0335    mgargmm@rediffmail.com   
Principal Investigator: Narendra Khippal, MD         
Sub-Investigator: Shantanu Sharma, MD         
Sub-Investigator: Sandeep Jasuja, MD         
Nehru Hospital & Post Graduate Institute of Medical Education Recruiting
Chandigarh, India, 160012
Contact: M Shashank, MS    +91-988-805-8173    ethicscare@ecrsindia.com   
Principal Investigator: Navneet Singh, MD         
Sub-Investigator: D Behra, MD         
Sub-Investigator: R Kapoor, MD         
Sponsors and Collaborators
BioMarck Pharmaceuticals, Ltd.
Investigators
Study Director: Devesh Verma, PhD Cliantha Research, India
More Information
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Responsible Party: BioMarck Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT03472053     History of Changes
Other Study ID Numbers: BIO-NSCLC-001
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
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