Personalized cancer therapy for Cancer

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/02/011808
• Date of registration: 09-02-2018
• Prospective Registration: No
• Primary sponsor: Datar Cancer Genetics Limited
• Public title: Personalized cancer therapy for Cancer
• Scientific title: 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.)
• Date of first enrolment: 16-12-2017
• Target sample size: 200
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=22150
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 2/ Phase 3

Countries of recruitment

India

Contacts

• Name: Dr Darshana Patil
• Affiliation: Datar Cancer Genetics Limited

• Name: Dr Darshana Patil
• Affiliation: Datar Cancer Genetics Limited

Key inclusion & exclusion 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;

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: 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



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Metastatic refractory, relapsed / recurrent metastatic solid organ cancer patients Health Condition 2: C00-D49- Neoplasms

Intervention(s)

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 non-chemotherapy drugs currently available in the market will be administered to the study participants.These drugs will be selected based on results of in-vitro and molecular analysis of tumor sample and patients blood sample.
Control Intervention1: The drugs taken during most recent chemotherapy (just before enrollment on study project) as per standard of care will be the comparator agent: In this trial chemotherapy and non-chemotherapy drugs currently available in the market will be administered to the study participants.These drugs will be selected based on results of in-vitro and molecular analysis of tumor sample and patients blood sample. The results of response to such drugs selected based on comprehensive cancer molecular profiling will be compared with response obtained by last standard of care chemotherapy drugs.

Primary Outcome(s)

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 Outcome(s)

Any other incidental or significant observation or finding relevant for the science or clinical management of cancer;Timepoint: Six months from completion of study

Secondary ID(s)

NIL

Source(s) of Monetary Support

Datar Cancer Genetics Limited, F-8, D Road MIDC Ambad, Nashik, Maharashtra 422010.

Ethics review

Status: Approved
Approval date: 12/12/2017
Contact:

Datar Cancer Genetics Limited Ethics Committee

Status: Approved
Approval date: 14/12/2017
Contact:

Manavata Clinical Research Institute Ethics Committee