Clinical trial NCT03253575: CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS)-2
Official title: CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS)-2: A Prospective, Multicenter, Observational Study Examining the Clinical Utility of CANscriptTM in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Adult Solid Tumor
Keywords: Head and Neck Squamous Cell Carcinoma
Breast Cancer
Non-Small Cell Lung Cancer
Epithelial Ovarian Cancer
Colorectal Cancer
Local Recurrent Cancer
Late Stage Cancer
Clinical Utility
Outcomes Study
Lead sponsor: Mitra RxDx, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-18
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males or females ≥18 years old, with an ECOG performance status of ≤2 who have recurrent locally advanced or metastatic cancers of the Head and Neck, Colorectal, Triple Negative Breast, Epithelial Ovarian, or Non-Small Cell lung cancers.

Brief summary: 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.

Detailed description: This is an observational data collection study evaluating how physicians utilize therapeutic sensitivity information ascertained with CANscript, and subsequently describing clinical outcomes (clinical response and survival) resulting from their therapeutic selection.

Potential patients presenting for study enrollment will provide written informed consent and will subsequently be screened per inclusion/ exclusion criteria. Once enrolled, a biopsy \& blood draw will be scheduled to obtain material for CANscript testing. Imaging will also be scheduled if a fresh image (obtained within 14 days of planned treatment initiation) is not available. Prior to submitting a fresh tissue sample for CANscript, the treating physician will select any number of therapies being considered for treatment, and will assign a priority ranking to those therapies (priority #1 through priority #N, with #1 representing their most preferred therapeutic option for the patient, and #N representing the number of their least preferred of the appropriate potential therapies). Prioritized therapies can be either single-agent therapeutics or combination regimens. All ranked therapeutic options must be available for individual patient at the time of selection. The prioritized list of preferred therapies will be sent to the testing laboratory (Mitra Biotech, Inc.) at least 2 days before the biopsy and blood draw are performed. Fresh tumor and blood samples will subsequently be sent to the testing laboratory for receipt within 24 hours of biopsy.

Eligibility criteria: Inclusion Criteria:

1. Male or female patient ≥18 years old
2. ECOG performance status of ≤ 2
3. The patient's tumor must be amenable to a tumor biopsy sampling, so that CANscript can be performed
4. 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)
5. 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
6. Patient has signed informed consent prior to initiation of any study-specific procedures

Exclusion Criteria:

1. 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).
2. 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).
3. 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.
4. 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).
5. 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.
6. 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.
7. The patient is receiving immunosuppressive therapy for prophylaxis following a prior organ transplant (solid organ or allogeneic stem cell). Corticosteroid therapy is permitted.
8. 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.
9. 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.

Primary outcomes:
measure: CANscript decision impact will be captured via a study specific questionnaire
timeFrame: 18-24 months
Secondary outcomes:
measure: The RECIST 1.1 criteria will utilized to assess therapy response, i.e. Complete Response (CR), Partial Response (PR), Stable Disease (SD), Duration of Response (DoR), Progression Free Survival (PFS)
timeFrame: 24-48 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Aurora
country: United States
facility: University of Colorado School of Medicine-Denver
state: Colorado
city: Norwich
country: United States
facility: Eastern CT Hematology and Oncology Associates
state: Connecticut
city: Boca Raton
country: United States
facility: Lynn Cancer Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Oncology Associates
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami-Sylvester Comprehensive Cancer Center
state: Florida
city: Miramar
country: United States
facility: The Center for Gyencologic Oncology
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Cancer Center
state: Florida
city: Savannah
country: United States
facility: Memorial Health University Medical Center- Savannah Health Services
state: Georgia
city: Joliet
country: United States
facility: Joliet Oncology Associates
state: Illinois
city: Naperville
country: United States
facility: Edward Elmhurst Healthcare
state: Illinois
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: Fairhaven
country: United States
facility: Southcoast Centers for Cancer Care
state: Massachusetts
city: Farmington Hills
country: United States
facility: Michigan Center of Medical Research -MHP
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: St John Hospital and Medical Center (Great Lakes Cancer Managment Specialists)
state: Michigan
city: Sault Sainte-Marie
country: United States
facility: War Memorial Hematology/Oncology
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Hospital
state: Missouri
city: Rochester
country: United States
facility: University of Rochester/Wilmot Cancer Institute
state: New York
city: Nashville
country: United States
facility: Saint Thomas Health
state: Tennessee
city: Austin
country: United States
facility: Austin Cancer Centers
state: Texas
city: Edinburg
country: United States
facility: Doctors Hospital at Renaissance-DHR Health
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston(UTMB)
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Hemtology/Oncology
state: Texas
city: Houston
country: United States
facility: Houston Methodist Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston- Hermann
state: Texas
city: McAllen
country: United States
facility: Invesclinic US McAllen Oncology
state: Texas
Study officials:
affiliation: Chief Medical Officer Mitrabiotech
name: Eric Rowinsky, MD
role: STUDY_CHAIR
References: