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CTRI Number  CTRI/2013/06/003768 [Registered on: 19/06/2013] Trial Registered Retrospectively
Last Modified On: 20/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study to evaluate the efficacy and safety of NRC-AN-019 in cancer patients failing prior standard therapies  
Scientific Title of Study   A Phase II Clinical Study to evaluate the efficacy and safety of NRC-AN-019 in cancer patients failing prior standard therapies  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SLNR019 Vesrion I September 2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr D Raghunadharao 
Designation  Professor  
Affiliation  Nizam’s Institute of Medical Sciences 
Address  Dept. of Medical Oncology Nizam’s Institute of Medical Sciences Punjagutta, Hyderabad

Hyderabad
ANDHRA PRADESH
500082
India 
Phone    
Fax    
Email  telerama@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  G Venkata Ramana  
Designation  Coordinator-Drug Development 
Affiliation   
Address  NATCO Pharma Limited NATCO House Road No. 2, Banjara Hills Hyderabad

Hyderabad
ANDHRA PRADESH
500033
India 
Phone  919849034389  
Fax    
Email  gvramana@natcopharma.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Praveen C Myneni 
Designation  Coordinator-Drug Development 
Affiliation  Sponsor 
Address  NATCO Pharma Limited NATCO House Road No. 2, Banjara Hills Hyderabad

Hyderabad
ANDHRA PRADESH
500033
India 
Phone    
Fax    
Email  drpraveen@natcopharma.co.in  
 
Source of Monetary or Material Support  
NATCO Pharma Limited 
 
Primary Sponsor  
Name  NATCO Pharma Limited 
Address  NATCO Pharma Ltd NATCO House Road No. 2, Banjara Hills Hyderabad – 500 033, INDIA  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Pravas Chandra Mishra  All India Institute of Medical Sciences  Department of Hematology, All India Institute of Medical Sciences, New Delhi 110029
New Delhi
DELHI 
01126594670

pravas_mishra@rediffmail.com 
Dr Senthil JRajappa  Basavatarakam Indo American Cancer Hospital and Research Institute  Basavatarakam Indo American Cancer Hospital and Research Institute Road No 14 Banjara Hills Hyderabad 500034
Hyderabad
ANDHRA PRADESH 
04023552131

siddarth142@sify.com 
Dr D Raghunadharao  Nizam’s Institute of Medical Sciences  Dept. of Medical Oncology Nizam’s Institute of Medical Sciences Punjagutta, Hyderabad 500082
Hyderabad
ANDHRA PRADESH 
04023489089

telerama@rediffmail.com 
Dr Rakesh Kapoor  Postgraduate Institute of Medical Education & Research  Dept. of Radiotherapy & Oncology Postgraduate Institute of Medical Education & Research Sector 12 Chandigarh 160012
Chandigarh
CHANDIGARH 
01722756396

drkapoor.r@gmail.com 
Dr S Bhattacharyya   Saroj Gupta Cancer Center and Research Institute  Surgical Oncology Saroj Gupta Cancer Center and Research Institute Thakurpukur Kolkata
Kolkata
WEST BENGAL 
03324532781

drsamir30951@yahoo.co.in 
Dr Kumar Prabhash  Tata Memorial Hospital  Dept. of Medical Oncology Tata Memorial Hospital Dr Ernest Borges Marg Parel, Mumbai 400012
Mumbai
MAHARASHTRA 
02224177000

kprabhash1@gmail.com 
Dr Sonia Parikh   The Gujarat Cancer & Research Institute  The Gujarat Cancer & Research Institute M.P.Shah Cancer Hospital NCH Campus Asarwa Ahmedabad
Ahmadabad
GUJARAT 
07922680575

gcri.clinicaltrials@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Basavatarakam Indo American Cancer Hospital and Research Institute  Submittted/Under Review 
Ethical Committee Saroj Gupta Cancer Center and Research Institute  Submittted/Under Review 
Ethics Committee Nizam’s Institute of Medical Sciences  Not Applicable 
GCRI/GCS Ethics Committee  Approved 
Institute Ethics Cmmittee-PGIMER  Approved 
Institute Ethics Committee All India Institute of Medical Sciences   Not Applicable 
Tata Memorial Hospital  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  1. Patients with metastatic or locally advanced or inoperable solid tumors who have received prior treatment 2. Chronic Myeloid Leukemia patients who are resistant and/or intolerant to Imatinib,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE   NOT APPLICABLE  
Intervention  NRC-AN-019  NRC-AN-019 is a small molecule tyrosine kinase inhibitor. Dose - 300 mg; Frequency - Daily; Route of administration - Oral; Total Duration of therapy - 6 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Histologically or cytologically confirmed metastatic or locally advanced or inoperable Pancreatic Cancer, Non-Small Cell Lung Cancer (NSCLC), Breast Cancer, Glioma, Colorectal Cancer, Ovarian Cancer and Head & Neck Cancer. Imatinib resistant and/or intolerant in case of GIST and CML
2. Male and female patients with age between 18 and 65 years
3. Must not have received chemotherapy or irradiation or any other investigational product within 14 days of entry to the trial
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Patients must have measurable lesion, defined as that can be measured in at least one dimension (longer diameter)
≥20 mm with conventional technique (CT/MRI) or as ≥ 10 mm with spiral CT
6. Patients with a probable minimum life expectancy ≥ 6 months
7. Must have adequate organ and marrow function
8. Renal function (normal serum creatinine and blood urea nitrogen)
9. Liver function (total bilirubin level ≤2 times upper normal limit (UNL) and serum transaminases levels ≤ 2.5 times UNL. ≤ 5 times for liver metastasis and/or obstructive jaundice).
10. WBC at least 3,000/mm3, neutrophil count ≥2000/mm3, platelet count ≥ 1,00,000.mm3 and hemoglobin level 8.0 g/dL
 
 
ExclusionCriteria 
Details  1. The patient has not recovered from clinically-meaningful toxicity due to prior therapy (i.e., back to baseline or Grade less than or equal to 1), with the exception of neurotoxicity and alopecia
2. The patient has uncontrolled intercurrent illness including ongoing or active infection, diabetes mellitus, hypertension, symptomatic congestive cardiac failure, unstable angina pectoris, stroke or myocardial infarction within 3 months.
3. The patient is either pregnant or lactating
4. Patients who have tested positive to HIV or HBsAG or HCV
5. Patients with brain metastasis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Solid Tumors:
1. PFS of at least 3 months for all tumors
2. ORR as per RECIST criteria
CML:
1. Evaluation of MaHR and/or MCyR 
During Visit 2 to Visit 9 
 
Secondary Outcome  
Outcome  TimePoints 
1.All adverse events will be graded as per NCI-CTCAE criteria (version 4.0)
2. Molecular response for CML patients
 
During Visit 2 to Visit 9 
 
Target Sample Size   Total Sample Size="270"
Sample Size from India="270" 
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 2 
Date of First Enrollment (India)   01/08/2012 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not published yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Despite significant advances in systemic therapies, radiotherapy, and surgical techniques, cancer still remains incurable. One of the approaches that have been recently used widely is to target the receptor tyrosine kinases. These kinases are often over expressed and/or mutated in many tumors and thus regulate proliferation, apoptosis, angiogenesis, tumor invasiveness and distant metastases.

 

NRC-AN-019 is a small molecule tyrosine kinase inhibitor discovered and developed by NATCO Pharma Limited, a pharmaceutical company based in Hyderabad, INDIA. The drug has been patented by NATCO in several countries.

 

The  proposed Phase-II clinical trial entitled "A Phase II Clinical Study to evaluate the efficacy and safety of NRC-AN-019 in cancer patients failing standard prior therapies" will be conducted in the following indications:

 

1. Pancreatic Cancer

2. NonSmall Cell Lung Cancer

3. Breast Cancer

4. Glioma

5. Colorectal Cancer

6. Ovarian Cancer

7. Head and Neck Cancer

8. Gastro-intestinal stromal tumors (GIST)

9. Chronic Myeloid Leukemia (CML)

 

  
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