Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Syndrome

Colorectal Neoplasms

Colorectal Neoplasms, Hereditary Nonpolyposis

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neoplastic Syndromes, Hereditary

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Genetic Diseases, Inborn

DNA Repair-Deficiency Disorders

Metabolic Diseases

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Lipid Regulating Agents

Aspirin

Atorvastatin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Atorvastatin (LIPITOR) 20 milligram tablet daily for 6 weeks

Atorvastatin (LIPITOR) 20 milligram tablet and Aspirin 325 mg tablet daily for 6 weeks

No history of colorectal cancer and no colorectal adenomas within 5 years.

Atorvastatin 20mg

History of colorectal cancer and/or history of colorectal adenomas within 5 years.

Atorvastatin 20mg AND Aspirin 325 mg

Yana Chertock, MA

Michael Hall, MD, MS

Michael J Hall, MD, MS

Margie L Clapper, PhD

Minhhuyen T Nguyen, MD,AGAF,FACP

Harry S Cooper, MD

Wen-Chi L Chang, PhD

The goal of this study is to investigate that a common cholesterol lowering agent (atorvastatin) alone or combining with a nonsteroidal anti-inflammatory drug (aspirin) would reduce the risk of colorectal cancer (CRC) in high-risk individuals with Lynch syndrome.

This is an exploratory biomarker trial to assess the ability of atorvastatin (common cholesterol lowering agent) alone or combining with aspirin (a nonsteroidal anti-inflammatory drug) to reduce the risk of colorectal cancer in high-risk individuals with Lynch Syndrome. Subjects will be stratified based on their prior history of polyps/cancer to receive atorvastatin without or with aspirin for 6 weeks. Blood and normal colon biopsies will be obtained at Day 0 and at 6 weeks on study. Tissue endpoints for analysis include cell proliferation, apoptosis and changes in gene expression. Circulating lipid profiles and metabolic function, and post-treatment questionnaires will be used to assess the acceptability of the study.

One group receives atorvastatin 20 mg, and the other group receives atorvastatin 20 mg+ aspirin 325mg

Atorvastatin ± Aspirin in Lynch Syndrome Syndrome

Impact of Atorvastatin ± Aspirin on Colorectal Biomarkers in Patients With Lynch Syndrome: a Pilot Study

Individual participant data that underline the results reported in the article , after de-identification

Effect of Atorvastatin or/and Aspirin on normal colonic proliferation and apoptosis will be evaluated by comparing of immunohistochemical staining of Ki-67 and active caspase 3 using formalin-fixed paraffin-embedded biopsies collected before and at the 6 weeks of drug treatments. Number of positive cells and total number of evaluated cells will be collected for both assays. Data of cells with positive Ki-67 or active caspase 3 will be expressed as % of positive cells (# positive cells/#total evaluated cells x 100). Statistical analyses will be performed to compare the difference between baseline and 6-weeks data.

Effect of Atorvastatin or/and Aspirin on gene expressions in normal colonic epithelial cells will be analyzed using RNA-Seq. Total RNA will be extracted from frozen biopsies. RNASeq libraries will be generated and sequenced on an Illumina platform and analyzed. Differential expression between samples at baseline and 6-weeks of drug treatment will be assessed for statistical significance. Genes with false discovery rat ≤ 0.05 and a fold-change ≥ 2 will be considered significant.

Medication Adherence to the 6-week course of Atorvastatin or/and Aspirin preventive therapy will be assessed by one question in the follow -up survey which participants complete at the end of the study :"Over 6 weeks of preventive therapy, how many Atorvastatin/Aspirin pills did you forget to take?" In addition, participants will be asked to return medication bottle(s) with or without pills. RA will count pills and record number of missing pills in the system.

The adverse event assessment form is used to collect initial and follow-up information for non-serious and serious adverse events for patients participating in the study. Participants are contacted by RA every two weeks to assess side effects and toxicity. A grading scale from 1 to 5 (1-mild, 2-moderate, 3-severy, 4-life-threatining, 5- death related to AE) and causality (1-unrelated, 2-unlikly, 3-possible, 4-probable, 5-definite, NA- not assessed) are recorded for each adverse event (AE) term. Each AE is reviewed by principal investigator and entered into patient's electronic medical record (EMR)

Acceptability of the study approach 6 Likert-type items (7 point scale) will assess participants' perceptions of various aspects of the study design as a measure of whether changes need to be made to the study methods or design prior to a larger multi-institutional trial. Participants' scores will be summed and a mean score generated. Mean scores \> 4 will be considered in the acceptable range. Our threshold target is 75% of participants with a mean score in the acceptable range.

Fox Chase Cancer Center

Carcinoma

Ascites

Antineoplastic Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Antibodies

Antibodies, Monoclonal

Prednisolone

Immunomodulating Agents

Immunoglobulins

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Catumaxomab

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Patients will receive premedication of 25 mg (i.v.) prednisolone 30 minutes prior start of infusion of catumaxomab.

Catumaxomab will be infused i.p. with 3 hour constant rate infusions via an indwelling catheter.

Catumaxomab will be administered in a dosage identical to Arm A but without the prednisolone premedication.

Catumaxomab will be infused 4 times within 11 days as follows:

10 µg on day 0, 20 µg on day 3, 50 µg on day 7, 150 µg on day 10

Florian Lordick, PD Dr. med.

This is a randomized phase IIIb study investigating the treatment of malignant ascites due to epithelial cancer (carcinomas) with the trifunctional antibody catumaxomab. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the tolerability of 3 hour infusions of catumaxomab with and without premedication of prednisolone is evaluated.

A total of 208 patients with malignant ascites due to epithelial cancer will be allocated to two treatment groups in a 1:1 ratio.

Safety data of the completed pivotal phase II/III trial, IP-REM-AC-01, in which catumaxomab was administered as 6 hour i.p. infusion showed that most reported AEs were cytokine release-related symptoms such as fever, nausea, and vomiting (based on the pharmacodynamic mode of action of catumaxomab) and abdominal pain. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the current trial was designed to determine whether tolerability of the 3 hour infusion of catumaxomab with and without premedication of prednisolone. Prednisolone was chosen as additional premedication with the objective to reduce cytokine release related symptoms which might change with the switch from 6 to 3 h infusion time.

CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers

Two-arm, Randomized, Open-label, Phase IIIb Study Investigating the Safety of a 3 Hour i.p. Infusion of Catumaxomab With and Without Prednisolone Premedication in Patients With Malignant Ascites Due to Epithelial Cancer

Neovii Biotech

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Ovarian Cancer

Ovarian Epithelial Cancer

Cyclophosphamide

dose-escalating study and subjects enrolled in the study may receive a maximum of 6 cycles of the assigned regimen over 18 weeks. Each cycle will be 3 weeks (21 days) with cyclophosphamide on Day 1 and EMD 273066 on Days 2 to 4, followed by 17 days with no experimental pharmaceutical product.

Each cycle, cyclophosphamide at 300 mg/m2 given per institutional guidelines 1 day (22-28 hours) prior to 3 consecutive days of EMD 273066 as a 4-hour IV infusion at 1 of 6 planned dose levels of 0.5, 1, 2, 3, 4, or 6 mg/m2.

EMD 273066

Joseph O'Connor, MD

This study is looking at the safety and tolerability of the experimental biological drug EMD 273066 when given with low dose cyclophosphamide to patients with recurring EpCAM positive ovarian, prostate, colorectal or non-small cell lung cancers. EMD 273066 is an experimental biological drug that may increase the immune response to certain cancers. Patients will be enrolled in groups of 3, with each successive group receiving a higher dose if the prior group adequately tolerates the study medication.

EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide

A Study to Find the Highest Dose of Biological Study Drug (EMD 273066) That Can Be Given Safely to Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-Small Cell Lung Cancers When First Given a Low Dose of Cyclophosphamide

EMD Serono

Pancreatic Neoplasms

Stomach Neoplasms

Carcinoma, Hepatocellular

Pancreatic Cancer

Stomach Cancer

Hematinics

Fludarabine

Fludarabine phosphate

Liver Extracts

The first stage: single dose escalation The classic "3+3" dose escalation test. The starting dose refers to the results of the previous test of subsequent subjects. In this study, 3 increasing dose levels were set up, with 3 to 6 cases per dose.

* The first dose group is 3×10\^5/kg, allowing 10% dose error.
* The second dose group is 1×10\^6/kg, allowing 10% dose error.
* The third dose group is 3×10\^6/kg, allowing 10% dose error. Each dose group must complete the DLT observation before entering the next dose group; when the first subject in the same dose group has no DLT observed for at least 14 days after cell infusion, the subsequent subjects can receive cell infusion.

The second stage: combined radiofrequency/microwave ablation for the treatment of advanced digestive system malignant tumors with liver metastases

Pretreatment with fludarabine and cyclophosphamide EpCAM CAR-T Cells infusion

EPCAM CAR-T

Bowen Peng

Saixue Zhang

Yongle Xie

Yimin Mao, Dr

Bo Zhai, Dr

Weijia Fang, Doctor

Weijia Fang

A Phase I Clinical Study of Autologous T cells modified with chimeric antigen receptor targeting EpCAM ( EPCAM CAR-T) in Patients with malignant tumors of the digestive system (including advanced gastric cancer, colorectal cancer, liver cancer and pancreatic cancer) .

This is a phase I open-label, single and multiple infusion, dose escalation/cohort expansion study to evaluate the safety, cell pharmacokinetics, and preliminary efficacy of EPCAM CAR-T, infused intravenously in subjects who have been diagnosed with advanced malignant tumors of the digestive system (including advanced gastric cancer, colorectal cancer, liver cancer and pancreatic cancer) and refractory or intolerant to current standard systemic treatment.

Primary objectives:

•To evaluate the safety and tolerability of EPCAM CAR-T infused intravenously at escalating doses in patients with advanced malignant tumors of the digestive system.

Secondary objectives:

1. The treatment of EpCAM CAR-T for patients with advanced digestive system malignancies, according to the dose-limiting toxicity and clinical response, including Possible side effects, determine the maximum tolerated dose (MTD), extended recommended dose (RDE) and/or recommended phase II dose (RP2D).
2. Assess the correlation between the pharmacodynamic (PD) biomarkers of IMC001 and clinical efficacy; EpCAM CAR-T expands and persists in vivo Correlation between sexual and pharmacodynamic (PD) biomarkers and adverse events.
3. To evaluate the preliminary anti-tumor efficacy of EpCAM CAR-T in patients with advanced digestive system malignancies. According to the evaluation criteria for the efficacy of solid tumors (RECIST) Version V.1.1, Evaluation Criteria for Efficacy of Immunotherapy for Solid Tumors (iRECIST), using objective response rate(ORR), duration of remission (DOR), disease control rate (DCR) and progression-free survival (PFS) description preliminary Anti-tumor activity.
4. The incidence of treatment-related adverse events.

Exploratory purpose:

1. Assess changes in immune status of EPCAM CAR-T treatment.
2. Assess the change of CTC in the peripheral blood of patients and the clearance effect of CAR-T cell treatment on CTC.

single dose escalation The classic "3+3" dose escalation test. The starting dose refers to the results of the previous test of subsequent subjects. In this study, 3 increasing dose levels were set up, with 3 to 6 cases per dose.

IMC001 for Clinical Research on Advanced Digestive System Malignancies

Autologous T Cells Modified by Chimeric Antigen Receptor Targeting EpCAM for Clinical Research on Advanced Digestive System Malignancies

Pharmacokinetics is the "Implantation endpoint" which is defined as the number of copies of the IMC001 DeoxyriboNucleic Acid（DNA）in peripheral blood detected at each visit after infusion until any two consecutive test results are negative or below the detection limit. Duration of IMC001 Cell persistence is the period from the day of infusion to the first negative test result or result lower than the detection limit

The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause.

The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause.

The period from the day when the subject receives the first study treatment to the first recorded tumor progression(whether treated or not) or death of any cause, which occurs first

The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause.

The period from the first study treatment to any cause of death

The number of cases in which response (PR + CR) and stable disease (SD) are achieved from the start of cell infusion/the total number of evaluable cases (%).

The number of CTC before and after treatment was evaluated

Zhejiang University

professor

AM-928, which is a humanized anti-EpCAM monoclonal antibody developed by AcadeMab Biomedical Inc.

AM-928

Pi-Chun Li, Ph.D.

This is a Phase I, open-label, dose-escalation study for a novel cancer treatment, AM-928, intravenous infusion antibody for advanced solid tumor. The study is aimed to learn the safety, tolerability, pharmacokinetics, and preliminary efficacy profile of AM-928.

The dose escalation strategy will adopt accelerated titration combined with a Bayesian optimal interval (BOIN) design. Seven dose levels are designed and each participant will be assigned to a specific dose regimen depending on the time of enrollment. In the study, each participant will receive AM-928 treatment cycles till meeting any treatment discontinuation criterion and be followed for safety and long-term survival.

The whole study is expected to take approximately three years to complete.

This is a first-in-human Phase I, open-label, dose-escalation study to investigate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of AM-928 infusion in subjects with advanced solid tumors in multiple sites in Taiwan.

Eligible subjects will be dosed with different dosages of AM-928 in 1 of the 7 dose levels (0.1, 0.3, 1, 3, 6, 10, 15 mg/kg). Dose levels will be escalated from dose Level 1 at 0.3 mg/kg to Level 6 at 15 mg/kg of AM-928 (or may be de-escalated to Level -1 at 0.1 mg/kg), which will be administered (intravenous infusion) once weekly (QW) for 4 weeks (D1, D8, D15, D22) as a treatment cycle until any treatment discontinuation criterion is met. Basically, there will be no breaks between dosing cycles. From Cycle 4, intra-subject dose escalation may be applied if supported by preliminary safety and PK data.

The dose escalation strategy will adopt accelerated titration combined with a Bayesian optimal interval (BOIN) design. The accelerated titration will be adopted for 0.3 mg/kg, while the BOIN design will be adopted for other dose levels, including 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, and 15 mg/kg. In the "accelerated titration" stage, if any ≥ Grade 2 adverse event occurs, the current and subsequent dose groups will be changed to the BOIN dose escalation method. The target toxicity rate for the maximum tolerated dose (MTD) is ϕ= 0.3, and the maximum sample size is determined to be 30, maximum of 9 subjects per dose level. A cohort size of 3 and a maximum cohort number of 3 for each dose level will be adopted for subject recruitment. The dose escalation may end when one of the following criteria is met: (1) The planned sample size of 30 has been reached; (2) 9 subjects have been treated and evaluable for DLT at the next intended dose level (should not exceed 9 subjects at one dose level); (3) all doses explored appear to be overly toxic, and the MTD cannot be determined.

Safety of AM-928 Infusion in Advanced Solid Tumors

A Phase I, Open-Label, Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AM-928 Infusion in Subjects With Advanced Solid Tumors

The MTD is defined the highest dose level that is closely to the toxicity rated defined in the study.

The DLT is specified treatment-emergent events that occur in cycle 1 treatment period, graded by NCI-CTCAE v5.0, and causality to study drug cannot be clearly ruled out.

Number of participants with abnormal hematology (RBC, WBC with differentials (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), platelet count, hemoglobin, and hematocrit), biochemistry (Albumin, total cholesterol, total bilirubin, direct bilirubin, alkaline phosphatase (ALP), AST, ALT, gamma-glutamyl transferase (γ-GT), total protein, blood urea nitrogen (BUN), lactate dehydrogenase (LDH), creatine kinase (CK), creatinine, estimated glomerular filtration rate (eGFR; 2021 CKD-EPI), triglyceride, amylase, lipase, glucose, uric acid, bicarbonate, calcium, chloride, inorganic phosphorus, iron, magnesium, potassium, and sodium), coagulation (prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR)), urinalysis (specific gravity, pH, occult blood, leukocytes, glucose, protein, ketones, bilirubin, and urine sediment (RBC, WBC, casts, epithelial cells, crystal, and microorganism)), and Troponin-T results

The TEAE is defined as adverse event (AE) occurred after the study drug administration. All TEAE will be assessed for severity by the investigator based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

The infusion-related reaction is adverse reaction due to study drug and occurred during an infusion and for 2 hours after the infusion completes. The symptom includes but not limited to fever, hypotension, hypertension, rash, nausea, dizziness.

The grading of the laboratory abnormalities is assessed based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

A subject will be treated weakly, 4 doses in a cycle

Physical examination includes the following items: general appearance, skin, eyes, ears, nose, throat, head and neck (including thyroid), heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological system, and other body systems if applicable for describing the status of the subject's health.

The chest x-ray will be evaluated by the investigators and noted as "normal", "NCS" or "CS".

Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate, body temperature, and oxygen saturation (SpO2).

The results of ventricular rate, PR interval, QRS interval, QT interval, and QTc interval will be recorded.

Area under the serum concentration-time profile (AUC) from time zero (T0) to the time of the last quantifiable concentration

AUC from T0 extrapolated to infinite time

The volume of serum cleared of the drug per unit time.

The last pre-dose concentration at steady state before the next dose is administered

The proportion of treated subjects achieving the best overall response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1

The proportion of treated subjects having achieved Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) per RECIST 1.1

The percent increase in the tumor volume per month

Change in the sum of the diameters of the target lesions per month

ECOG- Eastern Cooperative Oncology Group performance status is a scale used to assess how the disease affects the daily living abilities, and determine appropriate treatment and prognosis. It is a simple measure of functional status that determines ability of patient to tolerate therapies in cancer

The EORTC QLQ-C30 is a patient-reported outcome (PRO) questionnaire to assess the quality of life of cancer patients. Version 3.0 will be applied.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Atorvastatin ± Aspirin in Lynch Syndrome Syndrome	NCT04379999	Lynch Syndrome	Atorvastatin 20... Atorvastatin 20...	18 Years - 75 Years	Fox Chase Cancer Center
CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers	NCT00822809	Cancer Neoplasms Carcinoma Malignant Ascit...	Catumaxomab Prednisolone	18 Years -	Neovii Biotech
EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide	NCT00132522	Ovarian Cancer Colorectal Canc... Carcinoma, Non-... Prostate Cancer	EMD 273066	18 Years -	EMD Serono
IMC001 for Clinical Research on Advanced Digestive System Malignancies	NCT05028933	Advanced Hepato... Advanced Colore... Advanced Gastri... Advanced Pancre...	EPCAM CAR-T	18 Years - 70 Years	Zhejiang University
EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide	NCT00132522	Ovarian Cancer Colorectal Canc... Carcinoma, Non-... Prostate Cancer	EMD 273066	18 Years -	EMD Serono
Safety of AM-928 Infusion in Advanced Solid Tumors	NCT05687682	Advanced Solid ...	AM-928	18 Years -	AcadeMab Biomedical Inc.
IMC001 for Clinical Research on Advanced Digestive System Malignancies	NCT05028933	Advanced Hepato... Advanced Colore... Advanced Gastri... Advanced Pancre...	EPCAM CAR-T	18 Years - 70 Years	Zhejiang University
EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide	NCT00132522	Ovarian Cancer Colorectal Canc... Carcinoma, Non-... Prostate Cancer	EMD 273066	18 Years -	EMD Serono

Spots Global Cancer Trial Database for epcam

Every month we try and update this database with for epcam cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for epcam

Every month we try and update this database with for epcam cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for epcam cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.