Clinical trial on Cancer patients

Recruiting

Conditions: 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,

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

1.Willing and able to provide voluntary informed consent and able to comply with protocol requirements 1.Age â€“ 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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Safety and tolerability of test product compared to reference product by monitoring adverse events.	Day 0 Day 28 Day 56 and Day 84

Locations (1): Sri Venkateshwara Hospitals
🇮🇳
Bangalore, KARNATAKA, India
Sri Venkateshwara Hospitals
🇮🇳Bangalore, KARNATAKA, India
Dr Satheesh C T
Principal investigator
9148103232
svhethics@gmail.com