CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS)-2

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Conditions studied: Adult Solid Tumor

In brief

The purpose of this study is to test the CANscript™ sensitivity assay, which is a new and different assay developed to test the sensitivity of different cancer types to physician selected therapies (both drugs and/or drug combinations) indicated for the stage and type of cancer for treatment. CANscript™ tests how a patients specific tumor reacts to the therapies being considered by the treating physician. CANscript™ test results have been shown to closely correspond with actual clinical results, providing physicians with information that may help him/her develop a more personalized cancer treatment and care plan based on the patients specific condition. The researchers want to see if CANscript™ test results are helpful in selecting the treatments prescribed and provided. There will be about 800 people taking part in this study, across 5 different tumor types. The study is designed to assess the decision impact of the CANscript™ test results in informing physicians in therapy selection.

Key facts

Study ID

NCT03253575

Run by

Mitra RxDx, Inc.

People needed

800

Starts

2017-07-13

Expected to finish

2019-12-15

Last updated by the study team

2019-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patient ≥18 years old
• ECOG performance status of ≤ 2
• The patient's tumor must be amenable to a tumor biopsy sampling, so that CANscript can be performed
• The patient must have disease that is measurable by standard imaging techniques, per the RECIST 1.1 (For patients with prior radiation therapy, measurable lesions must be outside of any prior radiation field[s], unless disease progression has been documented at that disease site subsequent to radiation)
• Histologically- or cytologically-confirmed:
• A Locally advanced or metastatic HNSCC; B Locally advanced or metastatic TNBC; C Locally advanced or metastatic Stage 3b or 4 NSCLC after failure of appropriate 1st line therapy (i) Patients with EGFR or ALK mutations must have received previous appropriate therapy; D Locally advanced or metastatic epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, after failure of 1st line platinum-based chemotherapy (i) Recurrent or persistent stage 3 or 4 disease requiring relapse histologic documentation; E Stage IV metastatic CRC
• Patient has signed informed consent prior to initiation of any study-specific procedures

You may not qualify if…

• The patient has persistent clinically significant toxicities (Grade ≥2) from previous anticancer therapy (excluding chronic Grade 2 chemotherapy-related neuropathy which is permitted, and excluding Grade 2-3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the Investigator, and can be managed with available medical therapies).
• The patient has received treatment with chemotherapy, external-beam radiation, or other systemic anticancer therapy within 14 days prior to study entry (42 days for prior nitrosourea or mitomycin-C). (Patients could have received supportive care therapeutics as appropriate).
• The patient has an additional active malignancy that may confound the assessment of the study endpoints. Patients with a past cancer history (active malignancy within 2 years prior to study entry) with substantial potential for recurrence must be discussed with the Sponsor before study entry. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including transitional cell carcinoma, cervical intraepithelial neoplasia), organ-confined prostate cancer with no evidence of progressive disease.
• The patient has 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).
• The patient has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant risk for pulmonary complications during the study.
• The patient has known active or suspected brain or leptomeningeal metastases. (Central nervous system [CNS] imaging is not required prior to study entry unless there is a clinical suspicion of CNS involvement). Patients with stable, treated brain metastases are eligible provided there is no evidence of CNS disease growth on imaging for at least 6 weeks following radiation therapy or other loco-regional ablative therapy to the CNS.
• The patient is receiving immunosuppressive therapy for prophylaxis following a prior organ transplant (solid organ or allogeneic stem cell). Corticosteroid therapy is permitted.
• The patient has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements.
• The patient is pregnant or breast-feeding. The patient has known positive status for human immunodeficiency virus active or chronic Hepatitis B or Hepatitis C.

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• University of Colorado School of Medicine-Denver — Aurora, Colorado, United States
• Eastern CT Hematology and Oncology Associates — Norwich, Connecticut, United States
• Lynn Cancer Institute — Boca Raton, Florida, United States
• Broward Oncology Associates — Fort Lauderdale, Florida, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• University of Miami-Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• The Center for Gyencologic Oncology — Miramar, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Tallahassee Memorial Cancer Center — Tallahassee, Florida, United States
• Memorial Health University Medical Center- Savannah Health Services — Savannah, Georgia, United States
• Joliet Oncology Associates — Joliet, Illinois, United States
• Edward Elmhurst Healthcare — Naperville, Illinois, United States
• Community Hospital — Munster, Indiana, United States
• Ochsner Health System — New Orleans, Louisiana, United States
• Southcoast Centers for Cancer Care — Fairhaven, Massachusetts, United States
• Michigan Center of Medical Research -MHP — Farmington Hills, Michigan, United States
• St John Hospital and Medical Center (Great Lakes Cancer Managment Specialists) — Grosse Pointe Woods, Michigan, United States
• War Memorial Hematology/Oncology — Sault Ste. Marie, Michigan, United States
• Mercy Hospital — St Louis, Missouri, United States
• University of Rochester/Wilmot Cancer Institute — Rochester, New York, United States
• Saint Thomas Health — Nashville, Tennessee, United States
• Austin Cancer Centers — Austin, Texas, United States
• Doctors Hospital at Renaissance-DHR Health — Edinburg, Texas, United States
• University of Texas Medical Branch at Galveston(UTMB) — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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