Health Condition 1: null- Metastatic refractory, relapsed / recurrent metastatic solid organ cancer patients Health Condition 2: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Available drugs will be individualized as per in vitro or molecular analysis reports or as applicable.
: This trial is not for any new drug or molecule. In this trial chemotherapy and n
Sponsors
Datar Cancer Genetics Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age â?? 18 to 70 years (male or female); 2. Cancer of any solid organ, Sarcomas, Melanomas 3. Should have ECOG score of maximum 2; 4. Patient should have progressed on at least 3 SOC lines, if any, of therapy and have no further SOC option/ option is beyond financial reach (such as immunotherapy/ targeted therapy etc.). Three SOC lines would include surgery / RT / Cytotoxic therapy / targeted therapy; 5. Patient should be willing and fit for fresh tissue biopsy for obtaining live tumor cells / tapping of ascetic fluid / pleural fluid/ CSF etc. as the case may be; 6. The last failed SOC therapy should have resulted in a Progression Free Survival of 7. Patient should be able and willing to undertake treatment as may be advised after the analysis by DCGL with good compliance history in the past; 8. Patient should be willing and ready for baseline PET Scan and/or CT and/or USG and/or MRI and follow-up scans (usually the first follow-up scan is after 30 days followed by further scans at 75 days and 120 days); 9. Patient is willing and can tolerate cytotoxic and targeted therapy (labelled / off-label / repurposed / natural tumor inhibiting supplements); 10. Female patient is not pregnant / lactating; 11. Provision of signed and dated informed consent form 12. Stated willingness to comply with all study procedures 13. Patients must have measurable disease on radiological imaging post biopsy to monitor treatment response
Exclusion criteria
Exclusion criteria: 1. Lymphomas, Leukemias, Myelomas. 2. Life threatening co-morbidities such as HIV, HPV, HBV, HCV, Tuberculosis, CHF, Impaired Hepatic or Renal Function or any psychological deficits etc. 3. Not fulfilling inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amongst others, the purpose of the study is to evaluate in study participants who are treated with therapy guidance obtained from integrative molecular and cytology analysis provided by the DCGL investigation platform (Exacta) â?? (a) Objective Response Rate (ORR); (b) Benefit of Progression Free Survival (PFS); (c) Quality of Life;Timepoint: The baseline evaluation will be conducted prior to beginning of therapy (preferably within prior two weeks of therapy initiation). Follow up evaluations will be usually conducted after 30 days followed by further scans at 75 days and 120 days and so on. The evaluation also will be conducted based on clinical need and judgement of the clinician. | — |
Secondary
| Measure | Time frame |
|---|---|
| Any other incidental or significant observation or finding relevant for the science or clinical management of cancer;Timepoint: Six months from completion of study | — |
Countries
India
Contacts
Public ContactDr Darshana Patil
Datar Cancer Genetics Limited
Outcome results
None listed