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CTRI Number  CTRI/2012/06/002736 [Registered on: 21/06/2012] Trial Registered Retrospectively
Last Modified On: 05/07/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A Safety, Tolerability, Pharmacokinetic, and Efficacy Study of Docetaxel Injection Concentrate for Nano-Dispersion (DICN) in Subjects With Lung Cancer (NSCLC) 
Scientific Title of Study   A Safety, Tolerability, Pharmacokinetic, and Efficacy Study of Docetaxel Injection Concentrate for Nano-Dispersion (DICN) in Subjects With Unresectable Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CLR_11_10 v01 06 Oct 2011 amnd00  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Mudgal Kothekar MD 
Designation  Associate Vice President - Clinical Development 
Affiliation  Sun Pharma Advanced Research Company Ltd.  
Address  Sun Pharma Advanced Research Company Ltd. 17-B, Mahal Industrial Estate, Off Mahakali Caves Road, Andheri (East), Mumbai 400093, India 022 66455645

Mumbai
MAHARASHTRA
400 093
India 
Phone  02266455645  
Fax    
Email  clinical.trials@sparcmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Mudgal Kothekar MD 
Designation  Associate Vice President - Clinical Development 
Affiliation  Sun Pharma Advanced Research Company Ltd.  
Address  Sun Pharma Advanced Research Company Ltd. 17-B, Mahal Industrial Estate, Off Mahakali Caves Road, Andheri (East), Mumbai 400093, India 022 66455645
17-B, Mahal Industrial Estate, Off Mahakali Caves Road, Andheri (East), Mumbai 400093, India
Mumbai
MAHARASHTRA
400 093
India 
Phone  02266455645  
Fax    
Email  clinical.trials@sparcmail.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Mudgal Kothekar MD 
Designation  Associate Vice President - Clinical Development 
Affiliation  Sun Pharma Advanced Research Company Ltd.  
Address  Sun Pharma Advanced Research Company Ltd. 17-B, Mahal Industrial Estate, Off Mahakali Caves Road, Andheri (East), Mumbai 400093, India 022 66455645  
17-B, Mahal Industrial Estate, Off Mahakali Caves Road, Andheri (East), Mumbai 400093, India
Mumbai
MAHARASHTRA
400 093
India 
Phone  02266455645  
Fax    
Email  clinical.trials@sparcmail.com  
 
Source of Monetary or Material Support  
Sun Pharma Advanced Research Company Ltd.  
 
Primary Sponsor  
Name  Sun Pharma Advanced Research Company Ltd 
Address  17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (East) Mumbai MAHARASHTRA 400093 India  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chetan Deshmukh  Deenanath Mangeshkar Hospital & Research Centre  Room No. 8, Annex Building, Near Mhatre Bridge, Erandawane, Pune 411004.
Pune
MAHARASHTRA 		 02066023000

drchetandeshmukh@rediffmail.com 
Dr Ragunadhrao  Department of Medical Oncology  Room No. 22,Nizams Institute of Medical Sciences, Punjagutta, Hyderabad - 500 082, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH 		 914023489360

telerama@rediffmail.com 
Dr Shekhar Patil  HCG, Bangalore Institute of Oncology  # 8, HCG Towers, Tower IV, P.Kalinga Rao Road, Sampangi Ramnagar, Bangalore - 560027
Bangalore
KARNATAKA 		 08040206000

sp_associates6@rediffmail.com 
Dr Niraj Bhatt  Kailash Cancer Hospital & Research Centre  Chamber - 2, Chemotherapy ward, Muni Seva Ashram, Goraj-391760, Tal. Vaghodia, Dist.: Vadodara, Gujarat. INDIA.
Vadodara
GUJARAT 		 912668268040

nirajbhatt1974@gmail.com 
Dr Minish Jain  KEM Hospital Research Centre  3 rd floor OPD, Day Care,Bhanu Koyaji Building, Sardar Moorliar Road, Rasta Peth, Pune 411011
Pune
MAHARASHTRA 		 02066037336

drminishjain@yahoo.in 
Dr Shailesh Bondarde  Shatabdi Super Speciality Hospital  Cabin No. 4, 1st Floor, G - 11, Suyojit City Centre, Opp Mahamarg Bus Stand, Mumbai Naka, Nashik 422005.
Nashik
MAHARASHTRA 		 02532501888

shaileshbondarde@yahoo.com 
Dr Kumar Prabhash  Tata Memorial Hospital  Cabin No. 204, 2nd Floor, Homi Bhabha Building, Medical Oncology Department,Dr. E Borges Road, Parel, Mumbai - 400 012 India
Mumbai
MAHARASHTRA 		 02224177000

kp_prabhash@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Ethics Committee of KEM Hospital Research Centre  Approved 
HCG-Central Ethics Committee  Approved 
Human Ethics Committee, Tata Memorial Centre  Approved 
Institutional ethics committee, Deenanath Mangeshkar Hospital and Research Centre  Approved 
Institutional Ethics Committee, Kailash Cancer Hospital & Medical Centre  Approved 
Nizams Institutional Ethics Committee  Not Applicable 
Shatabdi Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, Unresectable Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Docetaxel Injection Concentrate for Nano-dispersion (DICN)  DICN will be infused i.v. over 1-hour. The treatment period consists of six 3-week treatment cycles. 
Comparator Agent  Not applicable (single arm trial)  Not applicable (single arm trial) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Histologically or cytologically diagnosed unresectable locally advanced19 or metastatic NSCLC with taxane-based therapy a rational treatment option;
2.Must have been treated with at least one prior chemotherapy regimen or targeted EGFR inhibitor for locally advanced or metastatic NSCLC;
3.Male or female subjects with age 18 to 70 years, inclusive;
4.Performance status ≤ 2 on the ECOG performance scale;
5.Estimated life expectancy of at least 12-weeks;
6.Measurable or evaluable disease as per RECIST 1.1 criteria;
7.Adequate organ and immune system function as indicated by the following laboratory values, obtained ≤ 2 weeks prior to dosing:
•Hematology:ANC ≥ 1.5 × 109/L, Hemoglobin ≥ 9.0 g/dL, Platelets ≥ 100 × 109/L
•Renal:Serum creatinine ≤ 2.0 mg/dL
•Hepatic:Total bilirubin ≤ upper limit of normal (ULN, Aspartate aminotransferase (AST) ≤ 1.5 × ULN, Alanine aminotransferase (ALT) ≤ 1.5 × ULN, Alkaline phosphatase ≤ 5 × ULN
8.Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator (such as condoms, foams,jellies, diaphragm, intrauterine device, oral or long acting injected contraceptives) from at least 2 months prior to enrollment and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative serum pregnancy test;
9.Willing to participate and give written informed consent.
 
 
ExclusionCriteria 
Details  1.Prior adjuvant chemotherapy or biological therapy for relapsed NSCLC if completed less than 1 year prior to first relapse of locally advanced19 or metastatic disease (prior surgery or radiotherapy allowed);
2.Prior docetaxel therapy for NSCLC;
3.Clinically significant third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to enrollment;
4.Any other malignancy within 5 years with the exception of adequately treated basal or squamous cell skin cancer or adequately treated in situ carcinoma;
5.Known hypersensitivity to the study drugs or their excipients or analogs;
6.Treatment with any investigational agents within 30 days of enrollment;
7.Active and uncontrolled infection;
8.Psychiatric disorders or alcohol/chemical abuse that would interfere with consent or follow-up;
9.Presence of clinically symptomatic central nervous system (CNS) metastases or carcinomatous meningitis;
10.Pre-existing peripheral neuropathy (Grade 2 or higher – as per CTCAE);
11.Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for getting enrolled in the study;
12.Human immunodeficiency virus (HIV) positive or who have an Acquired Immune Deficiency Syndrome (AIDS)-related illness;
13.Prior radiation therapy to ≥ 25% of the bone marrow (e.g. whole pelvic radiation is allowed). Subjects must have recovered from the acute side effects of radiotherapy;
14.Prior bone marrow/stem cell transplantation;
15.Known Hepatitis B or C, or history of chronic active Hepatitis B or C
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Safety and Efficacy (Objective response rate as per RECIST, 1.1)  at the end of 6 cycles 
 
Secondary Outcome  
Outcome  TimePoints 
Best overall response as per RECIST, 1.1   during study phase 
Progression-free survival (PFS)  12 months and 18 months 
Overall survival (OS)  after a minimum of two cycles of treatment 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)
Modification(s)  		 27/06/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is an open label study to assess the safety, tolerability, pharmacokinetic, and efficacy of Docetaxel Injection Concentrate for Nano-Dispersion (DICN) in subjects with unresectable locally advanced or metastatic non small cell lung cancer (NSCLC). 
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