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D009362: Neoplasm Metastasis

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (12)


Name (Synonyms) Correlation
drug2526 Placebo Group Wiki 0.50
drug1247 Experimental Group Wiki 0.50
drug939 Covid-19 swab PCR test Wiki 0.50
Name (Synonyms) Correlation
drug1370 GNX102 Wiki 0.50
drug780 Chloroquine analog (GNS651) Wiki 0.50
drug1125 EHR-based Clinician Jumpstart Wiki 0.50
drug2082 Monalizumab Wiki 0.50
drug353 Avdoralimab Wiki 0.50
drug3332 T3011 Wiki 0.35
drug2208 Nivolumab Wiki 0.29
drug3231 Standard of care Wiki 0.11
drug3485 Tocilizumab Wiki 0.08

Correlated MeSH Terms (17)


Name (Synonyms) Correlation
D012878 Skin Neoplasms NIH 0.50
D012983 Soft Tissue Neoplasms NIH 0.50
D016491 Peripheral Vascular Diseases NIH 0.35
Name (Synonyms) Correlation
D058729 Peripheral Arterial Disease NIH 0.29
D014652 Vascular Diseases NIH 0.25
D008103 Liver Cirrhosis, NIH 0.25
D051437 Renal Insufficiency, NIH 0.22
D007676 Kidney Failure, Chronic NIH 0.19
D009369 Neoplasms, NIH 0.18
D006333 Heart Failure NIH 0.16
D008175 Lung Neoplasms NIH 0.16
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.14
D017563 Lung Diseases, Interstitial NIH 0.14
D002908 Chronic Disease NIH 0.14
D008171 Lung Diseases, NIH 0.11
D003141 Communicable Diseases NIH 0.04
D007239 Infection NIH 0.02

Correlated HPO Terms (10)


Name (Synonyms) Correlation
HP:0008069 Neoplasm of the skin HPO 0.50
HP:0001395 Hepatic fibrosis HPO 0.25
HP:0004950 Peripheral arterial stenosis HPO 0.22
Name (Synonyms) Correlation
HP:0000083 Renal insufficiency HPO 0.22
HP:0002664 Neoplasm HPO 0.19
HP:0100526 Neoplasm of the lung HPO 0.19
HP:0001635 Congestive heart failure HPO 0.17
HP:0006510 Chronic pulmonary obstruction HPO 0.17
HP:0006515 Interstitial pneumonitis HPO 0.14
HP:0002088 Abnormal lung morphology HPO 0.11

Clinical Trials

Navigate: Correlations   HPO

There are 4 clinical trials


1 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
Conditions
  1. Solid Tumor
  2. Metastatic Cancer
  3. Advanced Cancer
  4. Unresectable Solid Neoplasm
Interventions
  1. 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 years

Secondary 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 years

Description: 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 years

Description: To determine the pharmacokinetics (PK) of GNX102

Measure: Cmax: Maximum plasma concentration of GNX102 (μg)

Time: Through study completion, an average of 2 years

Description: 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 years

Description: 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 years

Description: To determine the pharmacokinetics (PK) of GNX102

Measure: CL: Clearance of GNX102 (L/hr)

Time: Through study completion, an average of 2 years

Description: 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 years

Description: 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 years

Other 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 years

Description: 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 years

Description: 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 years

Description: 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 years
2 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
Conditions
  1. Dementia
  2. Chronic Disease
  3. Neoplasm Metastasis
  4. Lung Neoplasm
  5. Pulmonary Disease, Chronic Obstructive
  6. Heart Failure,Congestive
  7. Liver Cirrhosis
  8. Kidney Failure, Chronic
  9. Lung Diseases, Interstitial
  10. Peripheral Vascular Disease
  11. Diabetes With End Organ Injury
  12. Palliative Care, Patient Care
  13. Health Care Quality, Access, and Evaluation
  14. Patient Care
  15. Inpatients
  16. Health Communication
  17. Patient Care Planning
Interventions
  1. Behavioral: EHR-based Clinician Jumpstart
MeSH:Neoplasms 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
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
3 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.

A 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
Conditions
  1. SARS-CoV-2 (COVID-19) Infection
  2. Advanced or Metastatic Hematological or Solid Tumor
Interventions
  1. Drug: Chloroquine analog (GNS651)
  2. Drug: Nivolumab
  3. Drug: Tocilizumab
  4. Other: Standard of care
  5. Drug: Avdoralimab
  6. 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 randomization

Secondary 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 randomization

Description: 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 28

Description: 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 28

Description: 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)
4 A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of T3011 in Advanced Cutaneous or Subcutaneous Malignancies

A phase 1, open-label, first-in-human study of T3011 monotherapy to evaluate the safety and tolerability of T3011 in patients with advanced cancers with cutaneous or subcutaneous tumor deposits who have progressed while receiving standard of care therapy or who will not benefit from such therapy.

NCT04370587
Conditions
  1. Head and Neck Cancer
  2. Soft Tissue Tumor and/or Sarcoma
  3. Neoplasm of Skin
  4. Neoplasm Metastasis
  5. Melanoma
  6. Lung Cancer
  7. Solid Tumor
Interventions
  1. Biological: T3011
  2. Biological: T3011
MeSH:Neoplasms Neoplasm Metastasis Soft Tissue Neoplasms Skin Neoplasms
HPO:Neoplasm Neoplasm of the skin

Primary Outcomes

Description: Number of participants in dose escalating arm with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.

Measure: Safety and tolerability of T3011 in dose escalating administration in patients with advanced cutaneous or subcutaneous malignancies

Time: From first dose of T3011 (Week 1 Day 1) until 60 days after the last T3011 injection (up to 2 years)

Description: Number of participants in dose expansion arm with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.

Measure: Safety and tolerability of T3011 in dose expansion administration in patients with advanced cutaneous or subcutaneous malignancies

Time: From first dose of T3011 (Week 1 Day 1) until 60 days after the last T3011 injection (up to 2 years)

Secondary Outcomes

Description: To evaluate the virus shedding following intratumoral injection

Measure: Presence and frequency of T3011 in serum, saliva, urine, and injection site/dressing

Time: Up to 24 months

Description: To evaluate IL-12 and anti-PD-1 antibody expression of T3011 post intervention.

Measure: Quantitative measurements of serum IL-12 and anti-PD-1 antibody concentration.

Time: Up to 24 months

Description: To evaluate the immunogenicity of anti-PD-1 antibody expressed by T3011 post intervention.

Measure: Presence of neutralizing antibodies of anti-PD-1 antibody for antidrug antibodies (ADAs) development

Time: Up to 24 months

Description: To evaluate the immunogenicity of T3011 viral vector post intervention.

Measure: Presence of anti-herpes simplex virus type 1 (HSV-1) antibody compared to baseline

Time: Up to 24 months

Description: ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Measure: Overall response rate (ORR)

Time: Up to 24 months

Description: DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments per RECIST 1.1.

Measure: Disease control rate (DCR)

Time: Up to 24 months

Description: DOR is defined as the time from the first met CR or PR until disease progression or death due to any cause, whichever occurs first.

Measure: Duration of response (DOR).

Time: Up to 24 months

Description: DR is defined as objective response (CR or PR) according to RECIST 1.1, with a duration of at least 6 months.

Measure: Durable response (DR)

Time: Up to 24 months

Description: To evaluate the progression free survival (PFS) and overall survival (OS) of participants.

Measure: Survival (assessment per RECIST 1.1 and immune-modified RECIST (imRECIST)).

Time: Up to 24 months

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

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