iquid biopsy for treatment guidance in cancer

Phase 2

• Conditions: Health Condition 1: C00-D49- Neoplasms

• Registration Number: CTRI/2019/02/017548
• 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: 29 May 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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);

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

14.Adequate organ function defined as:

a)Absolute neutrophil count >= 1,000/μL

b)Platelet count >= 50,000/μL

c)Total bilirubin <= 1.5x institutional upper limit of normal (IULN)

d)AST and ALT <= 2x IULN

e)Creatinine <= 2x IULN

f)Creatinine clearance >= 45 mL/min/1.73m2 for participants with creatinine levels above IULN

g)Albumin >= 2.5 g/dL

h)Prothrombin time (PT) and PTT 80% to 120% of institutional normal range

i)Left Ventricular Shortening Fraction (LVSF) >= 28% confirmed by echocardiogram (ECHO), or Left Ventricular Ejection Fraction (LVEF) >= 45% confirmed by echocardiogram or Multiple Uptake Gated Acquisition (MUGA).

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR): To evaluate the proportion of patients exhibiting objective response (OR) study guided therapy approach. OR includes Complete Response (CR) as well as Partial Response (PR). ORR is evaluated in compliance with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria for solid tumors.Timepoint: First after minimum two lines of therapy or one month, whichever is earlier. Therapy and follow up will be continued further

Secondary Outcome Measures

Name	Time	Method
1.Clinical Benefit Rate (CBR): <br/ ><br>2.Time to Tumor Progression (TTP): <br/ ><br>3.Progression Free Survival (PFS): <br/ ><br>4.Overall Survival (OS): <br/ ><br>5.Event Free Survival (EFS): <br/ ><br>6.Quality of Life (QOL): <br/ ><br>7.Any other incidental or significant observation or finding relevant for the science or clinical management of cancer. <br/ ><br>Timepoint: Dependent on each parameter