|drug3904||Talabostat Mesylate plus Pembrolizumab Wiki||0.58|
|drug3625||Simulation Intervention Wiki||0.58|
|D018358||Neuroendocrine Tumors NIH||1.00|
|D018288||Carcinoma, Small Cell NIH||0.58|
|D055752||Small Cell Lung Carcinoma NIH||0.41|
There are 3 clinical trials
The purpose of this study is to learn if a new drug, ONC201 can make tumors become smaller or go away completely. Investigators also want to learn if ONC201 can prevent new deposits of cancer from appearing in new places in participants (metastases). A phase 2 study of ONC201 in PC-PG (pheochromocytoma-paraganglioma) and other neuroendocrine tumors will determine whether inhibition of DRD2 (a member of the dopamine receptor family) is safe in unresectable, recurrent, locally advanced, refractory, or metastatic neuroendocrine cancers including PC-PG, desmoplastic small round cell tumor (DSRCT), Ewing sarcoma (PNET) or any other neuroendicrine tumor with a catecholamine or dopamine biomarker or autocrine or paracrine dependence on dopamine including cholangiocarcinoma and adrenal cortical carcinoma. ONC201 is an investigational (experimental) agent and has a favorable safety profile in phase 1 and early phase 2 clinical trials in advanced cancers. This study design has been chosen to see whether ONC201 is associated with reduction of anti-hypertension medications, safety and significant efficacy against neuroendocrine tumors, especially PC-PG.
Description: Complete Response (CR) Disappearance or fibrosis of all target lesions. Any pathologic lymph nodes must have reduction in short axis to <10mm and standardized uptake value (SUV) is <4. Partial Response (PR) At least 30% decrease in sum of longest diameters of target lesions (compared to initial on study baseline) and any decrease in SUV in Fludeoxyglucose 18F (18FDG) imaging Stable disease (SD) 0-29% decrease in sum of longest diameters of target lesions (compared to initial on study baseline) or 0-19% increase in sum of longest diameters of target lesions (compared to initial on study baseline). SUV may increase or decrease Progressive disease 20% or more increase of sum of longest diameters of target lesions (compared to initial on study baseline). The sum must also be at an increase of at least 5mm or one or more new lesions that are considered metastatic diseaseMeasure: Tumor response according to RECIST Criteria Time: Up to 1 Year
Description: Average time from beginning of treatment to progression, death, or one year, whichever comes first. An underlying clinical benefit rate of 25% would indicate that ONC201 has a therapeutic effect, whereas an underlying rate <5% would indicate a lack of activityMeasure: Average duration of lack of progression: Clinical response Time: Up to 1 Year
Description: time from beginning of treatment until death, or one year, whichever comes first.Measure: Overall survival Time: Up to 1 Year
Description: to achieve this secondary endpoint of anti-hypertensive medication reduction in PC-PG subjects (N=12) data at 3 months will be required. An underlying clinical benefit rate of 25% would indicate that ONC201 has a therapeutic effect, whereas an underlying rate <5% would indicate a lack of activityMeasure: Average change in anti-hypertensive medication Time: from beginning of treatment to 3 months
An open-label, multicenter, Phase 1b/2 study to determine the composite response rate of BXCL701 administered orally and daily, combined wit PEMBRO, in patients with mCRPC enrolled in Stage 2, with either Small Cell Neuroendocrine Prostate Cancer(SCNC)(Cohort A) or adenocarcinoma phenotype (Cohort B). This study will also assess other efficacy parameters as well as the safety of the combined treatment. This study will consist of two (2) stages. Lead-in Stage, in which the safety and tolerability of the combination will be assessed and confirmed. And the Efficacy Stage, in which patients will be treated with BXCL701 combined with PEMBRO.
Description: Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria; circulating tumor cell (CTC) conversion from >5/7.5 mL to <5/7.5 mL12; and a greater than 50% prostate-specific antigen (PSA) decline from baseline.Measure: Estimate the composite response rate of the combination of BXCL701 + PEMBRO Time: up to 36 months
Description: The median time frame with progression-free survival with the use of BXCL701 in combination with Pembro determined by radiographic evidence.Measure: Estimate the median radiographic progression-free survival (rPFS) of the combination of BXCL701 and PEMBRO in Cohort A and B Time: up to 36 months
Description: The median time frame with progression-free survival with the use of BXCL701 in combination with PembroMeasure: Estimate the median PSA progression-free survival (PSA PFS) of the combination of BXCL701 and PEMBRO in Cohort A and B. Time: up to 36 months
Description: The median time frame with overall survival with the use of BXCL701 in combination with PembroMeasure: Estimate the median overall survival (OS) of the combination of BXCL701 and PEMBRO in Cohort A and B. Time: up to 36 months
Description: The timeframe in which the tumor reacts to BXCL701 in combination with PembroMeasure: Estimate the median duration of response (DOR) of the combination of BXCL701 and PEMBRO in Cohort A and B. Time: up to 36 months
Description: Determines the frequency and severity of known and unknown adverse events with the use of BXCL701 in combination with PembroMeasure: Determine the risk profile of the use of BXCL701 in combination with PEMBRO. Time: up to 36 months
A huge number of initiatives about COVID-19 are ongoing and a growing number of publications regard the correlation between cancer patients in general and SARS-CoV-2 infection. Although it has been reported that cancer patients are at a higher risk of SARS-CoV-2 infection and COVID-19 complications, data collection about cases of NEN patients SARS-CoV-2 positive are scattered and related to single countries or institutions. Because of that and due to the rarity and heterogeneity of NEN it will be hard to have homogeneous, reliable, representative and reproducible data for drawing adequate clinical recommendations about NEN patients and COVID-19. Therefore we propose a global collection of data through an international database to describe and monitor NEN patients with SARS-CoV-2 infection. This retrospective/prospective collection of data can create a solid basis to check frequence of events, clinical management, clinical outcome, demographic, geographical, clinical and biological correlations. This will be helpful for the clinical and scientific community to get reliable information for a homogeneous clinical management of NEN patients during COVID-19 pandemic. The main goal is to get the as wide as possible representativity of the world situation.
Description: To evaluate the correlation between SARS-CoV-2 infection and the following parameters: major comorbidities, severe overall events (including death), chemotherapy for neuroendocrine tumor (NET), chemotherapy for neuroendocrine carcinoma (NEC), everolimus therapy, immunotherapy, peptide receptor radionuclide therapy (PRRT) and surgery or radiotherapy within the last 2 months.Measure: Correlation between clinical parameters and SARS-CoV-2 infection Time: 01/2020 - 12/2020
Description: To evaluate the impact of SARS-CoV-2 Infection in NEN patientsMeasure: Clinical outcome of SARS-CoV-2 Infection Time: 01/2020 - 12/2020
Description: demographic features of SARS-CoV-2 infected NEN patientsMeasure: major demographic features Time: 01/2020 - 12/2020
Description: Rate of grade, stage, status and primary site of NENsMeasure: type of NEN Time: 01/2020 - 12/2020
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