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Clinical Trials/CTRI/2018/02/011808
CTRI/2018/02/011808
Active, not recruiting
Phase 2

The assessment of potential benefits of molecular analysis and in vitro chemo response directed at opening treatment options for relapsed and refractory metastatic solid organ tumors. - RESILIeNT (The assessment of potential benefits of molecular analysis directed at opening treatment options for RElapsed and refractory metaStatIc SoLId OrgaN Tumors.)

Datar Cancer Genetics Limited0 sites209 target enrollmentTBD

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Datar Cancer Genetics Limited
Enrollment
209
Status
Active, not recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Datar Cancer Genetics Limited

Eligibility 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 \<90 days;
  • 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;

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

Outcomes

Primary Outcomes

Not specified

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