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
|
|
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
|
|
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)
|