Covid 19 Research using Clinical Trials (Home Page)
Report for D009362: Neoplasm Metastasis NIH
(Synonyms: Neoplasm M, Neoplasm Me, Neoplasm Meta, Neoplasm Metas, Neoplasm Metast, Neoplasm Metasta, Neoplasm Metastasi, Neoplasm Metastasis)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (12)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug303 | Avdoralimab Wiki | 0.50 |
| drug869 | Device used to record voice for screening Wiki | 0.50 |
| drug658 | Chloroquine analog (GNS651) Wiki | 0.50 |
| drug1153 | GNX102 Wiki | 0.50 |
| drug1773 | Monalizumab Wiki | 0.50 |
| drug1111 | Fisetin Wiki | 0.50 |
| drug949 | EHR-based Clinician Jumpstart Wiki | 0.50 |
| drug102 | ASP9801 Wiki | 0.50 |
| drug1883 | Nivolumab Wiki | 0.29 |
| drug2707 | Standard of care Wiki | 0.11 |
| drug2928 | Tocilizumab Wiki | 0.09 |
| drug2122 | Placebo Wiki | 0.03 |
Correlated MeSH Terms (15)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D016491 | Peripheral Vascular Diseases NIH | 0.35 |
| D058729 | Peripheral Arterial Disease NIH | 0.29 |
| D014652 | Vascular Diseases NIH | 0.29 |
| D008103 | Liver Cirrhosis, NIH | 0.25 |
| D051437 | Renal Insufficiency, NIH | 0.22 |
| D008175 | Lung Neoplasms NIH | 0.22 |
| D007676 | Kidney Failure, Chronic NIH | 0.19 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.18 |
| D006333 | Heart Failure NIH | 0.17 |
| D017563 | Lung Diseases, Interstitial NIH | 0.14 |
| D002908 | Chronic Disease NIH | 0.14 |
| D008171 | Lung Diseases, NIH | 0.12 |
| D009369 | Neoplasms, NIH | 0.10 |
| D003141 | Communicable Diseases NIH | 0.04 |
| D007239 | Infection NIH | 0.03 |
Correlated HPO Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001395 | Hepatic fibrosis HPO | 0.25 |
| HP:0004950 | Peripheral arterial stenosis HPO | 0.22 |
| HP:0000083 | Renal insufficiency HPO | 0.22 |
| HP:0100526 | Neoplasm of the lung HPO | 0.22 |
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.18 |
| HP:0001635 | Congestive heart failure HPO | 0.17 |
| HP:0006515 | Interstitial pneumonitis HPO | 0.14 |
| HP:0002088 | Abnormal lung morphology HPO | 0.12 |
| HP:0002664 | Neoplasm HPO | 0.10 |
There are 4 clinical trials
Clinical Trials
1 A Phase 1, Open-label Study of ASP9801, an Oncolytic Virus, Administered by Intratumoral Injection in Patients With Advanced/Metastatic Solid Tumors
The purpose of this study is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D). The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of ASP9801.
NCT03954067 Metastatic Cancer Solid Tumors Advanced Cancer Biological: ASP9801 MeSH:Neoplasm Metastasis
Primary Outcomes
Description: Incidence of dose limiting toxicities
Measure: Dose Limiting Toxicities (DLT) - dose escalation part Time: Up to 28 daysDescription: An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP.
Measure: Safety and tolerability assessed by Adverse Events (AEs) Time: Up to 12 monthsDescription: Number of participants with potentially clinically significant laboratory values.
Measure: Number of participants with laboratory value abnormalities and/or adverse events Time: Up to 12 monthsDescription: Number of participants with potentially clinically significant vital sign values.
Measure: Number of participants with vital sign abnormalities and /or adverse events Time: Up to 12 monthsDescription: 12-lead ECGs will be read and assessed locally. Any clinically significant adverse changes on the ECG will be reported as Adverse Events.
Measure: Safety assessed by 12- lead electrocardiograms (ECGs) adverse events Time: Up to 12 monthsSecondary Outcomes
Description: Percent change from baseline in sum of diameters of injected tumors per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and immune modified response evaluation criteria in solid tumors (imRECIST)
Measure: Percent change from baseline in antitumor activity of ASP9801 Time: Up to 12 monthsDescription: Partial Response (PR) + Complete Response (CR) per imRECIST
Measure: Objective Response Rate Time: Up to 12 monthsDescription: Viral DNA load will be summarized by cohort using descriptive statistics.
Measure: ASP9801 viral DNA in blood Time: Up to 12 monthsDescription: Viral DNA will be analyzed by quantitative polymerase chain reaction (qPCR).
Measure: Viral shedding of ASP9801 in saliva Time: Up to 12 monthsDescription: Viral DNA will be analyzed by qPCR.
Measure: Viral shedding of ASP9801 in urine Time: Up to 12 monthsDescription: Viral DNA will be analyzed by qPCR.
Measure: Viral shedding of ASP9801 in skin (cutaneous/subcutaneous only) Time: Up to 12 months2 A Phase I Study of GNX102 in Patients With Advanced Solid Tumors
GNX-001 is an open-label, phase 1, multicenter, dose-escalation and expansion study of GNX102 infused every 21 days. Approximately 30 patients may be enrolled in the dose escalation portion of this study. Once the MTD or recommended phase 2 dose (RP2D) has been identified, up to 15 additional patients may be enrolled in one or two expansion cohort(s) at one or two dose levels recommended by the Safety Review Committee) to confirm the safety profile of the RP2D and provide additional information on anti-tumor activity. Patients with adeno- or epithelial-cancers that have a likelihood of GNX102 targeted antigen expression based on previous studies, including colorectal, hepatocellular, non-small cell lung, gastric, breast, pancreatic, cutaneous, acral, or mucosal melanoma, esophageal, prostate, and epithelial uterine cancers, can be screened for enrollment in the study.
NCT04250597 Solid Tumor Metastatic Cancer Advanced Cancer Unresectable Solid Neoplasm Drug: GNX102 MeSH:Neoplasm Metastasis
Primary Outcomes
Description: If ≤ 1 of 6 patients has a dose limiting toxicity (DLT) after all previous dose testing the dose will be declared the Maximum Tolerable Dose (MTD).
Measure: maximum tolerated dose (MTD) Time: Through study completion, an average of 2 yearsSecondary Outcomes
Description: To evaluate antitumor activity of GNX102 by objective radiographic assessment
Measure: Antitumor activity of GNX102 Time: Through study completion, an average of 2 yearsDescription: To determine the AUC Area under the concentration curve of GNX102
Measure: AUC: Area under the concentration curve of GNX102 (μg × h/mL) Time: Through study completion, an average of 2 yearsDescription: To determine the pharmacokinetics (PK) of GNX102
Measure: Cmax: Maximum plasma concentration of GNX102 (μg) Time: Through study completion, an average of 2 yearsDescription: To determine the pharmacokinetics (PK) of GNX102
Measure: Tmax: Time to maximum plasma concentration of GNX102 (minutes) Time: Through study completion, an average of 2 yearsDescription: To determine the pharmacokinetics (PK) of GNX102
Measure: t1/2: Terminal phase half-life of GNX102 (minutes) Time: Through study completion, an average of 2 yearsDescription: To determine the pharmacokinetics (PK) of GNX102
Measure: CL: Clearance of GNX102 (L/hr) Time: Through study completion, an average of 2 yearsDescription: To determine the pharmacokinetics (PK) of GNX102
Measure: Vz: Apparent volume of distribution in the terminal phase of GNX102 (L) Time: Through study completion, an average of 2 yearsDescription: Dose-limiting AEs and toxicities will be used to establish the MTD and the recommended dose for phase 2 studies (RP2D)
Measure: Number of adverse events (AEs) and number of toxicities Time: Through study completion, an average of 2 yearsOther Outcomes
Description: To explore tumor expression of GNX102 targeted antigens as a biomarker to predict toxicity or response to GNX102
Measure: Exploratory Outcome: GNX102 targeted antigens (counts) Time: Through study completion, an average of 2 yearsDescription: To explore serum LeB / LeY antigen levels as a potential biomarker to predict toxicity or response to GNX102
Measure: Exploratory Outcome: Serum LeB / LeY antigen levels (counts) Time: Through study completion, an average of 2 yearsDescription: To explore biomarkers related to cancer type to predict toxicity or response to GNX102
Measure: Exploratory Outcome: Serum tumor-specific antigen levels (counts) Time: Through study completion, an average of 2 yearsDescription: To evaluate the development of anti-drug antibody (ADA) to GNX102
Measure: Exploratory Outcome: Anti-drug antibody (ADA) to GNX102 (counts) Time: Through study completion, an average of 2 years3 Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness
The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients over the age of 65 with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1) to evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion during the hospitalization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 30-day hospital readmissions; and 2) to conduct a mixed-methods evaluation of the implementation of the Jumpstart intervention, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative assessments of effectiveness, implementation and maintenance and qualitative assessments of clinician perspectives on barriers and facilitators to future implementation and dissemination.
NCT04281784 Dementia Chronic Disease Neoplasm Metastasis Lung Neoplasm Pulmonary Disease, Chronic Obstructive Heart Failure，Congestive Liver Cirrhosis Kidney Failure, Chronic Lung Diseases, Interstitial Peripheral Vascular Disease Diabetes With End Organ Injury Palliative Care, Patient Care Health Care Quality, Access, and Evaluation Patient Care Inpatients Health Communication Patient Care Planning Behavioral: EHR-based Clinician Jumpstart MeSH:Neoplasm Metastasis Lung Neoplasms Liver Cirrhosis Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial Renal Insufficiency Kidney Failure, Chronic Heart Failure Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Chronic Disease Neoplasms
HPO:Abnormal lung morphology Chronic pulmonary obstruction Cirrhosis Congestive heart failure Hepatic fibrosis Interstitial pneumonitis Interstitial pulmonary abnormality Left ventricular dysfunction Neoplasm Neoplasm of the lung Peripheral arterial stenosis Renal insufficiency Right ventricular failure
Primary Outcomes
Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.
Measure: EHR documentation of Goals of Care discussions Time: Assessed for the period between randomization and 30 days following randomization
Secondary Outcomes
Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU admissions Time: Assessed for the period between randomization and 30 days following randomization
Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU length of stay Time: Assessed for the period between randomization and 30 days following randomization
Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/Hospital use: Hospital length of stay Time: Assessed for the period between randomization and 30 days following randomization
Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: Hospital Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomization
Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: ICU Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomization
Description: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.
Measure: Intensity of care: Healthcare costs Time: 1 and 3 months after randomization
Description: From Washington State death certificates.
Measure: All-cause mortality at 1 year (safety outcome) Time: 1 year after randomization
Other Outcomes
Description: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.
Measure: Key Implementation Factors Time: 3 months after randomization
4 A Prospective, Controlled, Randomized, Multicenter Study to Compare the Efficacy of a Chloroquine Analog (GNS561), an Anti-PD-1 (Nivolumab), an Anti-NKG2A (Monalizumab), an Anti-interleukine-6 Receptor (Tocilizumab) and an Anti-C5aR (Avdoralimab) Versus Standard of Care in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 (COVID-19) Infection.
Primary Outcomes
Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.
Measure: EHR documentation of Goals of Care discussions Time: Assessed for the period between randomization and 30 days following randomizationSecondary Outcomes
Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU admissions Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU length of stay Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/Hospital use: Hospital length of stay Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: Hospital Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: ICU Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomizationDescription: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.
Measure: Intensity of care: Healthcare costs Time: 1 and 3 months after randomizationDescription: From Washington State death certificates.
Measure: All-cause mortality at 1 year (safety outcome) Time: 1 year after randomizationOther Outcomes
Description: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.
Measure: Key Implementation Factors Time: 3 months after randomizationA prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of a chloroquine analog (GNS561), an anti PD-1 (nivolumab), an anti-NKG2A (monalizumab), an anti-C5aR (avdoralimab) and an anti-interleukine-6 receptor (tocilizumab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit. According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts: - COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-PD1 vs anti-NKG2A vs standard of care (randomization ratio 1:1:1:1). - COHORT 2 (moderate/severe symptoms): GNS561 vs anti-IL6 vs anti-C5aR vs standard of care (randomization ratio 1:1:1:1).
NCT04333914 SARS-CoV-2 (COVID-19) Infection Advanced or Metastatic Hematological or Solid Tumor Drug: Chloroquine analog (GNS651) Drug: Nivolumab Drug: Tocilizumab Other: Standard of care Drug: Avdoralimab Drug: Monalizumab MeSH:Infection Communicable Diseases Neoplasm Metastasis
Primary Outcomes
Description: 28-day survival rate, defined by the proportion of patients still alive 28 days after randomization. The 28-day survival rate will be described in each arm of each cohort.
Measure: 28-day survival rate Time: 28 days from randomizationSecondary Outcomes
Description: Time to clinical improvement defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale (WHO-ISARIC) or live discharge from the hospital, whichever comes first.
Measure: Time to clinical improvement Time: 28 days from randomizationDescription: Clinical status will be assessed using a 7-point ordinal scale : Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.
Measure: Clinical status Time: Day 7, Day 14, Day 28Description: Mean change in clinical status from baseline will be assessed using a 7-point ordinal scale.
Measure: Mean change in clinical status from baseline to days Time: Day 7, Day 14, Day 28Description: Overall survival will be defined by the time from date of randomization until date of death, regardless of the cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
Measure: Overall survival Time: 3 months (i.e. at the the time of last patient last visit)Description: The length of stay in Intensive Care Unit (from the date of admission in the Unit to the date of discharge).
Measure: Length of stay in Intensive Care Unit Time: 3 months (i.e. at the the time of last patient last visit)Description: The duration of mechanical ventilation or high flow oxygen devices (from the date of intubation to the stop date of mechanical ventilation or high flow oxygen)
Measure: Duration of mechanical ventilation or high flow oxygen devices Time: 3 months (i.e. at the the time of last patient last visit)Description: The duration of hospitalization (from the date of hospitalization to the date of definitive discharge for live patients)
Measure: Duration of hospitalization Time: 3 months (i.e. at the the time of last patient last visit)Measure: Rate of throat swab negativation Time: Day 7, Day 14, Day 28
Measure: Quantitative SARS-CoV-2 virus in throat swab and blood samples Time: Day 7, Day 14, Day 28
Measure: Rate of secondary infection by other documented pathogens Time: Day 7, Day 14, Day 28 (if available)
Description: Changes from baseline in neutrophils count (G/L)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Treatment-Emergent Adverse Events, Serious Adverse Events, Suspected Unexpected Serious Adverse Reactions, New Safety Issues described using the NCI-CTC AE classification v5. Number of participants with a discontinuation or temporary suspension of study drugs (for any reason).
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Time: 3 months (i.e. at the the time of last patient last visit)Description: Incremental Cost-Effectiveness Ratios (ICERs) expressed in cost per Life Year Gained.
Measure: Cost-Effectiveness Analyses (CEA) Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in lymphocytes count (G/L)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in platelets count (G/L)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in hemoglobin count (g/dL)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in CRP count (mg/L)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in pro-inflammatory cytokine (IL6)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)