An observational study to assess the clinical utility of CANscript to inform the selection ofcancer treatment for patients with advanced cancers

Not Applicable

• Conditions: Health Condition 1: C50-C50- Malignant neoplasms of breastHealth Condition 2: C51-C58- Malignant neoplasms of female genital organsHealth Condition 3: C00-C14- Malignant neoplasms of lip, oral cavity and pharynxHealth Condition 4: C30-C39- Malignant neoplasms of respiratory and intrathoracic organsHealth Condition 5: C64-C68- Malignant neoplasms of urinary tractHealth Condition 6: C00-D49- Neoplasms

• Registration Number: CTRI/2018/09/015604
• Lead Sponsor: Dr Amit Verma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-09-30
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

1.Male or female patient �18 years of age.

2.Histologically- or cytologically-confirmed advanced, relapsed or refractory solid tumors.

3.Patients with known comprehensive genomic profiling evaluation using Foundation One within 6 months of enrolment in the study. This timeframe can be extended for up to one year if the patient has not received the active treatment as suggested by the comprehensive genomic profiling evaluation.

4.Patientââ?¬•s tumor amenable to a tumor biopsy sampling, so that CANscript can be performed.

5.ECOG 0-2.

6.Patient with measurable tumor target lesion as per RECIST1.1 criteria at baseline.

7.Patient willing to provide informed consent prior to participation in study.

Exclusion Criteria

1.Presence of an additional active malignancy that may confound the assessment of the study endpoints.

2.Presence of clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).

3.Presence of known active or suspected brain metastases.

4.Presence of uncontrolled intercurrent illness.

5.Female patient having known positive status for pregnancy or breast feeding.

6.The patient has known positive status for human immunodeficiency virus active or chronic Hepatitis B or Hepatitis C.

7.Participation in another research study within a period of 30 days prior to the date of enrollment.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To summarize the objective response rates with CANscript designated therapy in combination with comprehensive genomic profiling using Foundation One.Timepoint: 2-3 months

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR)Timepoint: time from the date measurement criteria are first met for CR or PR to the date measurement criteria are first met for PD;Growth Modulation Index GMITimepoint: 24 months