Personalized cancer therapy for Cancer

Phase 2

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

• Registration Number: CTRI/2018/02/011808
• Lead Sponsor: Datar Cancer Genetics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 209

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified