Study Stopped
Mitra is temporarily suspending enrollment in the ANCERS-2 clinical utility study due to unexpected test performance results, to analyze the test performance.
CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS)-2
ANCERS-2
1 other identifier
observational
800
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Typical duration for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 13, 2017
CompletedFirst Submitted
Initial submission to the registry
August 9, 2017
CompletedFirst Posted
Study publicly available on registry
August 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2019
CompletedApril 8, 2019
December 1, 2018
2 years
August 9, 2017
April 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CANscript decision impact will be captured via a study specific questionnaire
1\. A questionnaire will be used to capture the information to be able to summarize the concordance and discordance rates between: 1. Empirically selected therapy (selected by treating physicians prior to knowing the CANscript results for a given patient) and CANscript recommended therapy (i.e., the therapy with the highest CANscript M-score for a given patient). 2. Empirically selected therapy and CANscript results that predict response or non-response.
18-24 months
Secondary Outcomes (1)
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)
24-48 months
Study Arms (5)
Squamous Carcinoma of the Head and Neck (HNSCC)
1st line metastatic/locally advanced * 2nd line metastatic/locally advanced
Triple Negative Breast Cancer (TNBC)
1\. Triple Negative Breast Cancer (TNBC) A 1st line metastatic/locally advanced B ≥2nd line metastatic/locally advanced
Non-small Cell Lung Cancer (NSCLC)
1\. Non-small Cell Lung Cancer (NSCLC) A ≥2nd line Stage 3B or 4
Epithelial Ovarian Cancer (EOC)
1\. Epithelial Ovarian Cancer (EOC) A 2nd line platinum-resistant Stage 3 or 4 B 2nd line platinum-sensitive Stage 3 or 4 C ≥3rd line platinum-sensitive Stage 3 or 4
Colorectal Cancer (CRC)
1\. Colorectal Cancer (CRC) A 1st line Stage 4 B Recurrent or progressive disease following treatment with both oxaliplatin- and irinotecan-containing regimens
Interventions
CANscript is a predictive test that supports informed selection of cancer therapeutics for each individual patient. CANscript has the potential to predict the response of the patient under evaluation to either single-agent cancer therapeutics or combination therapeutic regimens. This is accomplished by using fresh tumor tissue from the patient in plates coated with a specific set of tumor matrix proteins (TMP). Further, patient derived autologous ligands are added to the culture. Angiogenic factors are added to maintain tumor vasculature along with autologous immune cells. In essence, CANscript recapitulates the tumor microenvironment.
Eligibility Criteria
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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mitra RxDx, Inc.lead
Study Sites (30)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
University of Colorado School of Medicine-Denver
Aurora, Colorado, 80045, United States
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
Lynn Cancer Institute
Boca Raton, Florida, 33486, United States
Broward Oncology Associates
Fort Lauderdale, Florida, 33308, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
University of Miami-Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
The Center for Gyencologic Oncology
Miramar, Florida, 33027, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Tallahassee Memorial Cancer Center
Tallahassee, Florida, 32308, United States
Memorial Health University Medical Center- Savannah Health Services
Savannah, Georgia, 31404, United States
Joliet Oncology Associates
Joliet, Illinois, 60435, United States
Edward Elmhurst Healthcare
Naperville, Illinois, 60540, United States
Community Hospital
Munster, Indiana, 46321, United States
Ochsner Health System
New Orleans, Louisiana, 70121, United States
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, 02719, United States
Michigan Center of Medical Research -MHP
Farmington Hills, Michigan, 48334, United States
St John Hospital and Medical Center (Great Lakes Cancer Managment Specialists)
Grosse Pointe Woods, Michigan, 48236, United States
War Memorial Hematology/Oncology
Sault Ste. Marie, Michigan, 49783, United States
Mercy Hospital
St Louis, Missouri, 63141, United States
University of Rochester/Wilmot Cancer Institute
Rochester, New York, 14642, United States
Saint Thomas Health
Nashville, Tennessee, 37205, United States
Austin Cancer Centers
Austin, Texas, 78758, United States
Doctors Hospital at Renaissance-DHR Health
Edinburg, Texas, 78539, United States
University of Texas Medical Branch at Galveston(UTMB)
Galveston, Texas, 77550, United States
Oncology Consultants
Houston, Texas, 77024, United States
Baylor College of Medicine Hemtology/Oncology
Houston, Texas, 77030, United States
Houston Methodist Medical Center
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston- Hermann
Houston, Texas, 77030, United States
Invesclinic US McAllen Oncology
McAllen, Texas, 78577, United States
Biospecimen
Tumor tissue biopsies and resections embedded formalin fixed paraffin and blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eric Rowinsky, MD
Chief Medical Officer Mitrabiotech
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2017
First Posted
August 18, 2017
Study Start
July 13, 2017
Primary Completion
July 31, 2019
Study Completion
December 15, 2019
Last Updated
April 8, 2019
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share