Adult Solid TumorANCERS-2NCT03253575
CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS)-2
An observational study of Adult Solid Tumor, run by Mitra RxDx, Inc. at 30 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Solid Tumor
- What is being tested?
- CANscript
- How many people
- 800 participants
- Where
- 30 sitesUnited States
- Study dates
- 13 Jul 2017to 15 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
University of Colorado School of Medicine-Denver
Aurora, Colorado, 80045
Austin Cancer Centers
Austin, Texas, 78758
Lynn Cancer Institute
Boca Raton, Florida, 33486
Doctors Hospital at Renaissance-DHR Health
Edinburg, Texas, 78539
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, 02719
Michigan Center of Medical Research -MHP
Farmington Hills, Michigan, 48334
Broward Oncology Associates
Fort Lauderdale, Florida, 33308
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
University of Texas Medical Branch at Galveston(UTMB)
Galveston, Texas, 77550
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
St John Hospital and Medical Center (Great Lakes Cancer Managment Specialists)
Grosse Pointe Woods, Michigan, 48236
Oncology Consultants
Houston, Texas, 77024
Baylor College of Medicine Hemtology/Oncology
Houston, Texas, 77030
Houston Methodist Medical Center
Houston, Texas, 77030
The University of Texas Health Science Center at Houston- Hermann
Houston, Texas, 77030
Joliet Oncology Associates
Joliet, Illinois, 60435
Invesclinic US McAllen Oncology
McAllen, Texas, 78577
University of Miami-Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
The Center for Gyencologic Oncology
Miramar, Florida, 33027
Community Hospital
Munster, Indiana, 46321
Edward Elmhurst Healthcare
Naperville, Illinois, 60540
Saint Thomas Health
Nashville, Tennessee, 37205
Ochsner Health System
New Orleans, Louisiana, 70121
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, 06360
Florida Hospital Cancer Institute
Orlando, Florida, 32804
University of Rochester/Wilmot Cancer Institute
Rochester, New York, 14642
War Memorial Hematology/Oncology
Sault Ste. Marie, Michigan, 49783
Memorial Health University Medical Center- Savannah Health Services
Savannah, Georgia, 31404
Mercy Hospital
St Louis, Missouri, 63141
Tallahassee Memorial Cancer Center
Tallahassee, Florida, 32308
About this study
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
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.
Read the 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.
- Conditions
- Adult Solid Tumor
- Being tested
- CANscript
- 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
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Ovarian Epithelial, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CANscriptDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Squamous Carcinoma of the Head and Neck (HNSCC) | 1st line metastatic/locally advanced
* 2nd line metastatic/locally advanced Receives: Diagnostic Test: CANscript | |
| Triple Negative Breast Cancer (TNBC) | 1. Triple Negative Breast Cancer (TNBC) A 1st line metastatic/locally advanced B ≥2nd line metastatic/locally advanced Receives: Diagnostic Test: CANscript | |
| Non-small Cell Lung Cancer (NSCLC) | 1. Non-small Cell Lung Cancer (NSCLC) A ≥2nd line Stage 3B or 4 Receives: Diagnostic Test: CANscript | |
| 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 Receives: Diagnostic Test: CANscript | |
| 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 Receives: Diagnostic Test: CANscript |
What is being measured
The primary outcome is the main question the study is designed to answer.
CANscript decision impact will be captured via a study specific questionnaire
- A questionnaire will be used to capture the information to be able to summarize the concordance and discordance rates between:
- 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).
- Empirically selected therapy and CANscript results that predict response or non-response.
Measured: 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)
A baseline Image will be taken prior to therapy initiation, and then as per tratment guidelines throughout and following therapy delivery:
- To summarize tumor response in terms of objective response rate (ORR), clinical benefit rate (CBR), duration of response (DoR) progression-free survival (PFS), and overall survival (OS) based on imaging (CT, MRI, etc.) and scoring per RECIST 1.1 criteria.
Measured: 24-48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start13 Jul 2017
- Primary completion31 Jul 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Why it stopped: Mitra is temporarily suspending enrollment in the ANCERS-2 clinical utility study due to unexpected test performance results, to analyze the test performance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitra RxDx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Rowinsky, MD, Study chair, Chief Medical Officer Mitrabiotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253575
- Sponsor's protocol ID
- MIT-201701
- Acronym
- ANCERS-2
- Status last verified
- Dec 2018
- First submitted
- 9 Aug 2017
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03253575
- Acronym / sponsor ID
- ANCERS-2 / MIT-201701
- 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
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Mitra is temporarily suspending enrollment in the ANCERS-2 clinical utility study due to unexpected test performance results, to analyze the test performance.
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Mitra RxDx, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Squamous Carcinoma of the Head and Neck (HNSCC) | – | Diagnostic Test: CANscript1st line metastatic/locally advanced * 2nd line metastatic/locally advanced |
| Triple Negative Breast Cancer (TNBC) | – | Diagnostic Test: CANscript1. Triple Negative Breast Cancer (TNBC) A 1st line metastatic/locally advanced B ≥2nd line metastatic/locally advanced |
| Non-small Cell Lung Cancer (NSCLC) | – | Diagnostic Test: CANscript1. Non-small Cell Lung Cancer (NSCLC) A ≥2nd line Stage 3B or 4 |
| Epithelial Ovarian Cancer (EOC) | – | Diagnostic Test: CANscript1. 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) | – | Diagnostic Test: CANscript1. Colorectal Cancer (CRC) A 1st line Stage 4 B Recurrent or progressive disease following treatment with both oxaliplatin- and irinotecan-containing regimens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CANscriptCANscript 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. | Diagnostic test | Colorectal Cancer (CRC), Epithelial Ovarian Cancer (EOC), Non-small Cell Lung Cancer (NSCLC), Squamous Carcinoma of the Head and Neck (HNSCC), Triple Negative Breast Cancer (TNBC) |
Primary outcome
CANscript decision impact will be captured via a study specific questionnaire
Time frame: 18-24 months
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.
1 secondary outcome
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)
Time frame: 24-48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Rowinsky, MD study chair
Chief Medical Officer Mitrabiotech
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Solid Tumor, run by Mitra RxDx, Inc. at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CANscript decision impact will be captured via a study specific questionnaire (time frame: 18-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.