CovidResearchTrials by Shray Alag


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Report for D018358: Neuroendocrine Tumors NIH

(Synonyms: Neuroendocrine Tum, Neuroendocrine Tumors)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)


Name (Synonyms) Correlation
drug2830 Talabostat Mesylate plus Pembrolizumab Wiki 0.58
drug1940 ONC201 Wiki 0.58
drug759 Convalescent Plasma of patients with COVID-19 Wiki 0.58
drug3409 placebo (hartmann plus albumine) Wiki 0.58

Correlated MeSH Terms (4)


Name (Synonyms) Correlation
D055752 Small Cell Lung Carcinoma NIH 0.58
D018288 Carcinoma, Small Cell NIH 0.58
D011471 Prostatic Neoplasms NIH 0.29
D009369 Neoplasms, NIH 0.12

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0100634 Neuroendocrine neoplasm HPO 1.00
HP:0030357 Small cell lung carcinoma HPO 0.58
HP:0012125 Prostate cancer HPO 0.29
HP:0002664 Neoplasm HPO 0.12

There are 3 clinical trials

Clinical Trials


1 Phase 2 Study of ONC201 in Neuroendocrine Tumors

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.

NCT03034200 Recurrent Neuroendocrine Tumor Metastatic Neuroendocrine Tumor Drug: ONC201
MeSH:Neuroendocrine Tumors Neoplasms
HPO:Neoplasm Neuroendocrine neoplasm

Primary Outcomes

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 disease

Measure: Tumor response according to RECIST Criteria

Time: Up to 1 Year

Secondary Outcomes

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 activity

Measure: 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 activity

Measure: Average change in anti-hypertensive medication

Time: from beginning of treatment to 3 months

2 Phase 1b/2 Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases, Administered in Combination With the Anti-Programmed Cell Death 1 Monoclonal Antibody Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype

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.

NCT03910660 Prostate Cancer Neuroendocrine Tumors Small Cell Carcinoma Drug: Talabostat Mesylate plus Pembrolizumab
MeSH:Prostatic Neoplasms Neuroendocrine Tumors Carcinoma, Small Cell Small Cell Lung Carcinoma
HPO:Neuroendocrine neoplasm Prostate cancer Prostate neoplasm Small cell lung carcinoma

Primary Outcomes

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

Secondary Outcomes

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 Pembro

Measure: 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 Pembro

Measure: 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 Pembro

Measure: 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 Pembro

Measure: Determine the risk profile of the use of BXCL701 in combination with PEMBRO.

Time: up to 36 months

3 InterNaTional rEgistry oN Sars-cov-2posItiVe nEuroendocrine Neoplasm Patients (INTENSIVE)

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.

NCT04444401 Neuroendocrine Tumors COVID-19
MeSH:Neuroendocrine Tumors
HPO:Neuroendocrine neoplasm

Primary Outcomes

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 patients

Measure: Clinical outcome of SARS-CoV-2 Infection

Time: 01/2020 - 12/2020

Secondary Outcomes

Description: demographic features of SARS-CoV-2 infected NEN patients

Measure: major demographic features

Time: 01/2020 - 12/2020

Description: Rate of grade, stage, status and primary site of NENs

Measure: type of NEN

Time: 01/2020 - 12/2020


HPO Nodes