CTRI/2019/02/017548
Active, Not Recruiting
Phase 2
To evaluate the efficacy of therapy administered based on guidance obtained from integrative molecular analysis of cell free nucleic acids and in vitro chemosensitivity analysis of circulating tumor cells, aimed at improving availability of therapy options and treatment outcomes in relapsed/refractory metastatic solid organ tumors with unavailability of de novo tissue biopsies. - LIQUID-IMPACT
Datar Cancer Genetics Limited0 sites0 target enrollmentTBD
ConditionsHealth Condition 1: C00-D49- Neoplasms
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Sponsor
- Datar Cancer Genetics Limited
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For Inclusion, an individual must meet all of the following criteria:
- •1\.Age â?? 18 to 70 years (male or female);
- •2\.Refractory/relapsed, advanced/unresectable/metastatic histologically documented solid organ malignancy
- •3\.Should have ECOC score of maximum 2 and a life expectancy of at least 3 months
- •4\.Patient should have progressed on at least one SOC lines of therapy OR have no further SOC option/ option is beyond financial reach OR there must not be other approval/standard therapy available that has been shown to prolong overall survival OR therapy naïve patients where no agreed upon standard of care (SOC) options exist OR patients who cannot receive other standard therapy that has been shown to prolong overall survival due to medical issues will be eligible. (SOC lines would include surgery / RT / Cytotoxic therapy / targeted therapy)
- •5\.If the patient is currently receiving therapy, the clinician must have assessed that the current therapy is no longer benefitting the patient prior to enrolling
- •6\.Patient should be willing and fit for requisite blood or body fluid sampling required for study purpose e.g. ascitic fluid / pleural fluid/ CSF etc. as the case may be;
- •7\.Patient should be physically and financially able 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);
Exclusion Criteria
- •1\.Patients who fail to meet all of the iclusion criteria will be excluded. Failing to meet any single criteria would be sufficient grounds for exclusion.
- •2\.Prior malignancy other than types included in study
- •3\.Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
- •4\.Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening.
- •5\.Serious co\-morbidities such as, but not limited to severe cardiac failure severe pulmonary compromise or severe and active infections, HIV, HPV, HBV, HCV, Tuberculosis etc.
- •6\.Patient has an investigational medicinal product within the last 30 days prior to screening.
- •7\.Pregnant or nursing women.
- •8\.Psychiatric illness with potential to affect study compliance
Outcomes
Primary Outcomes
Not specified
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