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CTRI Number  CTRI/2021/10/037293 [Registered on: 13/10/2021] Trial Registered Prospectively
Last Modified On: 17/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial on Cancer patients  
Scientific Title of Study   A Prospective, open label, Case study to determine the safety and efficacy of AB001 with Standard of Care in patients with advanced metastatic cancer 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Dinesh 
Designation  Senior Scientific officer  
Affiliation  Agastiya Biotech  
Address  B-13, Mogappair Industrial Estate, Mogappair West, Chennai TAMIL NADU

Chennai
TAMIL NADU
600 037
India 
Phone  9952063729  
Fax    
Email  rnd@agastiyabiotech.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Dinesh 
Designation  Senior Scientific officer  
Affiliation  Agastiya Biotech  
Address  B-13, Mogappair Industrial Estate, Mogappair West, Chennai TAMIL NADU

Chennai
TAMIL NADU
600 037
India 
Phone  9952063729  
Fax    
Email  rnd@agastiyabiotech.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Dinesh 
Designation  Senior Scientific officer  
Affiliation  Agastiya Biotech  
Address  B-13, Mogappair Industrial Estate, Mogappair West, Chennai TAMIL NADU

Chennai
TAMIL NADU
600 037
India 
Phone  9952063729  
Fax    
Email  rnd@agastiyabiotech.com  
 
Source of Monetary or Material Support  
Agastiya Biotech B-13, Mogappair Industrial Estate, Mogappair West, Chennai 
 
Primary Sponsor  
Name  Agastiya Biotech 
Address  B-13, Mogappair Industrial Estate, Mogappair West, Chennai 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Satheesh C T   Sri Venkateshwara Hospitals   Secod floor Dept. of Medical Oncology 27, 29th Main Road, Rashtra Kuvempu Nagara, BTM 2nd stage, BTM layout,
Bangalore
KARNATAKA 		 9148103232

svhethics@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Venkateshwara Hospitals Ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, (2) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (3) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (4) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (5) ICD-10 Condition: C228||Malignant neoplasm of liver, primary, unspecified as to type, (6) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, (7) ICD-10 Condition: C249||Malignant neoplasm of biliary tract, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AB001 along with Chemotherapy   Dosage form: Tablet Dose : 400mg Twice daily Duration: 84 Days  
Comparator Agent  Standard chemotherapy   Based on principal investigator protocol  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Willing and able to provide voluntary informed consent and able to comply with protocol requirements
1. Age – 20 to 70 years
2. Patients with advanced Cancer not amenable to surgical therapy.
3. Patients must have measurable disease on radiological imaging of CT / MRI / PET scan to monitor treatment response. Measurable disease, as defined by RECISTv1.1.
4. Patients Undergoing is allowed to take part in the study.
5. Women of child bearing potential must agree to either use a contraceptive method or to remain abstinent during the treatment period and for at least 3 months after the last dose of study drug.
6. Life expectancy > 24 weeks
7. Patient should be willing to undergo all treatment related procedures and investigations
8. Patient should be willing and ready for PET Scan, Blood Investigations, PK, ECG and follow-up.
9. Patient is willing to take and to tolerate cytotoxic drugs.
10. No history of addiction to any recreational drug or drug dependence.
12. Non-smokers and non-alcoholics
 
 
ExclusionCriteria 
Details  1. Patients above 70yrs of age
2. Pregnant or lactating women, or intending to become pregnant during the study.
3. Life threatening comorbidities such as HIV, HPV, HBV, HCV, Tuberculosis, CHF, Impaired Hepaticor Renal Function or any psychological deficits etc.
4. Known CNS disease, except for treated asymptomatic CNS metastases.
5. Uncontrolled pleural effusion, pericardial effusion, orascites
6. Uncontrolled tumor-related pain
7. Significant cardiovascular disease, such as New York Heart As Standard of Careiation (NYHA) cardiac disease (Class II or greater), MI within 3 months prior to randomization, unstable arrhythmias, or unstable angina.
8. Major surgical procedure within 4weeks prior to randomization or anticipation of the need for a major surgical procedure during the study other than for diagnosis.
9. History of autoimmune disease.
10. Prior allogeneic stem cell or solid organ transplantation
Poor peripheral venous access
11. Any other medical condition or uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.) that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
12. Patients not suitable for study as per investigators opinion.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the Clinical Benefit Rate -Complete Response (CR) + Partial Response (PR) + Stable Disease (SD), Tumor Reduction   Day 0 Day 28 Day 56 and Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
Safety and tolerability of test product compared to reference product by monitoring adverse events.  Day 0 Day 28 Day 56 and Day 84 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   15/10/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 The biggest challenge in current therapeutics of chemo drugs is the inability to kill cancer stem cells (CSCs) which are capable of self-renewal, proliferation and differentiation. Secondary challenge is the surviving of these CSCs which lead to relapse, metastasis and drug resistance. Most conventional cancer therapy fails to destroy cancer cells which leads to relapse of the disease and mortality. Most studies reported that the existing chemo drugs have limited penetration to the CSCs due to their hypoxic microenvironment and distant location away from the vasculature that retards the efficacy of the drugs. We developed a novel Small molecule inhibitor AB001 which target selectively on cancer cells and cancer stem cells with increase bioavailability, efficacy and fastest tissue distribution in advance stage metastatic cancer. 
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