Feasibility Trial of Darwin OncoTreat and OncoTarget Precision Medicine Testing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGood Samaritan Hospital Medical Center, New York
About this trial
This is a feasibility trial to assess use of OncoTarget and OncoTreat testing in a basket design of patients with oligmetastasis across various solid tumor histology. Eligible oligometastatic patients that are receiving radiation therapy (n=20) will undergo mandatory tumor biopsy prior to precision medicine testing. Formalin fixed paraffin embedded tissue with \>50% tumor will be sent to the Laboratory of Personalized Genomic Medicine at Columbia University Medical Center for Darwin OncoTarget and OncoTreat testing. This will be supplementing routine clinical care with the goal of improving outcomes. The treating oncologist will decide to administer standard of care systemic therapy or proceed with treatment recommended by precision medicine testing. Feasibility outcomes include the ability to have the OncoTarget and OncoTreat test performed based on tumor type and pathology, ability to procure agents, change in medication use, and identification of unknown barriers. This study is assessing the use of precision medicine in a population has documented poor outcomes with implications aimed at improving these outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients age ≥18 years with metastatic solid tumor who are candidates for comprehensive involved site radiotherapy to all areas of disease seen on whole body imaging.
Patients with brain metastases are eligible provided they qualify as oligometastases (up to 10 lesions based on the SABR-COMET-10 trial) and are treatable with radiotherapy to all areas of visible disease.
Patients with adequate bone marrow (absolute neutrophil ≥1000, hemoglobin ≥ 9 g/dl, platelets ≥100,000), kidney (creatinine ≤1.5 times upper limit of normal) and liver (bilirubin ≤1.5 times upper limit of normal).
Patients being treated by radiation oncology at Good Samaritan University Hospital.
Disqualifiers
Patients with an estimated median survival of less than 6 months using the published and validated NEAT methodology.
Patients who are pregnant and/or breast feeding or those with severe uncontrolled cardiac, pulmonary, infectious or organic brain disease.
Trial design
Design model
Single group
Treatments tested in this trial
Darwin OncoTarget and OncoTreat
Diagnostic testDarwin OncoTarget and OncoTreat predict potential drugs with early markers of efficacy in early human clinical trials. Specifically, OncoTarget identifies high-affinity inhibitors of master regulator proteins, while OncoTreat identifies tumor-checkpoint module inhibitors that modulate the transcriptional activity of hyper-connected master regulators. These tests are now commercially available with Clinical Laboratory Improvement Amendments (CLIA) approval through Columbia Presbyterian Medical Center.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: FeasibilityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility: Test Performance Ability To Perform Test Versus Unable to Perform Test with Pathology Samples Needed >50% Tumor Tissue
Proportion of participants whose tumor biopsy successfully undergoes OncoTarget and OncoTreat testing based on sufficient cellularity/DNA/RNA, defined as \>50% tumor.
Time frame
Through study completion, an average of 2 years2
Feasibility: Percent Medication Change Versus No Medication Change Based on Treating Medical Oncologist Decision
Percentage of participants whose chemotherapy management plan is changed based on the willingness of the medical oncologist to try at least one off-label medication recommended by Darwin testing.
Time frame
Through study completion, an average of 2 years3
Feasibility: Percent Medication Procured Through Insurance and/or Compassionate Use Versus Unable to Attain
Out of the participants who are prescribed a drug from Darwin testing, the percentage that are procured FDA approved on-label and/or off-label agents through insurance or compassionate use in the setting of extensive preauthorization requirements prevalent in community oncology practice.
Time frame
Through study completion, an average of 2 years4
Feasibility: Qualitative Measurement of Barriers Noted Throughout Study
Quantification and explanation of any unknown barriers that occur throughout the study process preventing an eligible participant from starting a drug recommended by Darwin testing.
Time frame
Through study completion, an average of 2 yearsSecondary outcomes
1
Systemic Therapy Change Compared to Standard of Care
The proportion of cases where OncoTarget and OncoTreat testing, compared to standard of care genomic testing including Foundation One or Caris, results in a change in systemic treatment that can be implemented in a community hospital setting.
Time frame
Through study completion, an average of 2 years2
Progression-Free Survival
Progression-free survival defined as the time between enrollment and tumor progression or death for patients with oligometastases treated with comprehensive involved site radiotherapy compared to historical control patients treated without OncoTarget and OncoTreat testing.
Time frame
Patients will be followed as per standard of care, up to 5 years or until death. Event determined from date of enrollment until first documented progression or death from any cause, whichever came first, assessed up to 5 years.Sponsors and contacts
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Source ClinicalTrials.gov
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