Health Condition 1: C249- Malignant neoplasm of biliary tract, unspecified Health Condition 2: C189- Malignant neoplasm of colon, unspecified Health Condition 3: C23- Malignant neoplasm of gallbladder Health Condition 4: C228- Malignant neoplasm of liver, primary, unspecified as to type Health Condition 5: C508- Malignant neoplasm of overlappingsites of breast Health Condition 6: C259- Malignant neoplasm of pancreas, unspecified Health Condition 7: C169- Malignant neoplasm of stomach, unsp
Conditions
Interventions
Intervention1: AB001 along with Chemotherapy: Dosage form: Tablet
Dose : 400mg Twice daily
Duration: 84 Days
Control Intervention1: Standard chemotherapy: Based on principal investigator protocol
Sponsors
Agastiya Biotech
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide voluntary informed consent and able to comply with protocol requirements 1. Age ââ?¬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
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of test product compared to reference product by monitoring adverse events.Timepoint: Day 0 Day 28 Day 56 and Day 84 | — |
Primary
| Measure | Time frame |
|---|---|
| To assess the Clinical Benefit Rate -Complete Response (CR) + Partial Response (PR) + Stable Disease (SD), Tumor ReductionTimepoint: Day 0 Day 28 Day 56 and Day 84 | — |
Countries
India
Contacts
Public ContactDr Dinesh
Agastiya Biotech
Outcome results
None listed