Aung Naing, MD

Primary Objective:

-Evaluate incidence of cardiac complications in Phase I patients.

Secondary Objective:

-To identify variables (i.e. number of electrocardiograms (EKG) performed) that lead to the detection of cardiac events.

The research plan includes a retrospective review of the chart of past UT MD Anderson Cancer Center (MDACC) patients and the experience in treating them.

All studies analyzed will be Phase I clinical trials.

Analysis is designed to collect information on the number of and timeframe within which ECGs are performed on these trials. Data on adverse events and serious adverse events, dose modifications based on ECG changes, attribution to drug, incidence and types of ECG changes specifically QTC prolongation as well as their influence on study procedures like dose limiting toxicities (DLTs) in dose escalation phase of the studies.

Study conducted using clinical records of patients treated on Phase I protocols in the MDACC Department of Investigational Cancer Therapeutics. The demographic data to be collected from patients whose charts will be analyzed will include variables such as age, gender, primary cancer, stage of the disease, performance status, treatment characteristics (i.e., number and type of prior therapies), disease status, adverse events, laboratory data (i.e., complete blood count/differential/platelets, tumor markers), and treatment outcomes.

The analysis will allow identification and descriptive analysis of the occurrence of cardiac events in the phase I population and will help define the role of protocol required EKGs in their detection.

HIPAA privacy and confidentiality guidelines will be followed. The database will be secured in the Department server. A Data coordinator has been recruited to undertake this project. The information derived from these observations will help the investigators formulate research questions and projects to develop future prospective studies.

The statistical analysis will be performed in a descriptive fashion with paired and multivariable analyses.

The analyses will be reported using summary tables, figures, and data listings. Continuous variables will be summarized using the mean, standard deviation, median, minimum, and maximum.

This study will be conducted at the MD Anderson Cancer Center in Houston, Texas.

The Role of the EKG in Anticancer Drug Development

The Role of the EKG in Anticancer Phase I Drug Development

Data review of studies, active between January 1, 2006 and December 31, 2009, who included ECGs in their safety evaluations. Use of identification and descriptive analysis of cardiac events occurrence in the phase I population to define role of protocol required EKGs in their detection. Statistical analysis performed in a descriptive fashion with paired and multivariable analyses.

M.D. Anderson Cancer Center

Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Rare Diseases

Neuroendocrine Tumors

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Adenoma

Adenoma, Islet Cell

Endocrine Gland Neoplasms

Multiple Endocrine Neoplasia

Multiple Endocrine Neoplasia Type 1

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplasms, Glandular and Epithelial

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neoplasms, Multiple Primary

Syndrome

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Pancreatic Cancer

All Drugs and Chemicals

Hormones

Retrospective review of a prospectively maintained MEN1 database.

Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.

Database reviewed to obtain patient and disease characteristics, laboratory values, imaging results, hormone parameters (menopausal status, bioidentical hormone use, oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.

Chart Review

Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.

Questionnaire

Nancy D. Perrier, MD

OBJECTIVES:

The primary objective of this study is to evaluate the effect of estrogen on the development of the PNET in MEN1 patients.

The secondary objective is to evaluate the overall survival and disease specific survival in patients who have confirmed MEN1 with or without PNET and a pancreatic neuroendocrine tumor in relation to their hormone status. The secondary objective is to evaluate clinicopathologic features in relation to hormone status.

Retrospective review of a prospectively maintained MEN1 database. The patient cohort consists of all patients with confirmed MEN1 with or without PNET who are included in the database. The database will be reviewed to obtain patient and disease characteristics, laboratory values, imaging results, hormone parameters (menopausal status, bioidentical hormone use, oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.

For the prospective portion of this study, investigators want to see the impact of estrogen on the PNET forming and progression, and would like to use two equations to assess the estrogen exposure, so investigators should collect the information of menopause, menarche, breast feed, HRT, OCP use and pregnancy. To this end, investigators will contact female patients in the database who are still living, and obtain verbal informed consent to send an email questionnaire regarding their pregnancy and hormone use history.

Overall and Disease Specific Survival in Patients With Confirmed MEN1 With or Without PNET (Pancreatic Neuroendocrine Tumors)

Time to PNET calculated starting from the date of menarche time to the PNET diagnostic date or the menopause date (for the patients who get the menopause prior to the PNET diagnosis) or the last follow-up date.

Overall survival estimated and plotted using Kaplan-Meier method (Kaplan, 1958)(4).

Nervous System Diseases

Substance Related Disorders

Parkinson Disease

Malignant Carcinoid Syndrome

Serotonin Syndrome

Carcinoid Tumor

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Adenocarcinoma

Carcinoma

Carcinoid Syndrome

Cardiotonic Agents

Psychotropic Drugs

Neuroprotective Agents

Herbal and Botanical

Dopamine

Antidepressive Agents

Dopamine Agonists

Serotonin

Rasagiline

Monoamine Oxidase Inhibitors

Enzyme Inhibitors

Protective Agents

St. John's Wort

Group R+AD Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) for at least 14 days

At least 2 months of Anti-PD and Rasagiline

Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) at least 14 days

Group R+AD Rasagiline + Antidepressant

Group R Rasagiline

An approved dopaminergic medication for PD. (2 months of treatment with an antidepressant medication.

Group AD Anti-PD + Antidepressant

Tom Smith, MD

To identify the occurrence of serotonin toxicity in Parkinson's Disease (PD) patients receiving antidepressant therapy and rasagiline, compared to those receiving rasagiline without antidepressant medications and compared to PD patients receiving antidepressants, but not rasagiline.

Azilect + Antidepressant Chart Review

Investigation of the Occurrence of Serotonin Toxicity in Parkinson's Disease (PD) Patients Treated Concomitantly With Rasagiline and Antidepressants, Using Retrospective Chart Review

Teva Branded Pharmaceutical Products R&D, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Mobocertinib

Participants diagnosed with advanced NSCLC with EGFR exon 20 insertions (ex20ins) mutations who were treated according to routine clinical practice will be observed retrospectively up to 6 months or until the end of follow-up.

Study Director

The main aim is to see how treatment patterns and drugs might improve care for adults with advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon-20 driven mutations. Past medical records will be reviewed. No clinic visits or procedures will be required.

This is a retrospective, observational study in participants with advanced NSCLC with EGFR exon-20 driven mutations. This study will look at clinical outcomes, patterns of care and disease management strategies and healthcare resource utilization (HCRU) in a routine clinical practice setting in the real world.

The study will enroll approximately 218 participants. Participants who were treated at the participating sites between 01 January 2017 and 30 November 2021 will be included. The data will be collected retrospectively at the specialized centers from the participants medical records and notes. All the participants will be assigned to a single observational cohort:

• Participants With Advanced NSCLC With EGFR Exon-20 Mutations

This multi-center study will be conducted in Canada, France and Hong Kong. The overall duration of the study will be 6 months.

A Chart Review Study of Adults With Advanced NSCLC

Patterns of Care and Clinical Outcomes of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

rwPFS is defined as the time elapsed from the initiation of a new treatment line to real-world progressive disease (rwPD) or death, whichever occurred first. rwPD: unequivocal increase in visible disease/disease burden or presence of new lesions. Participants will be censored at the end of the line of therapy or date of last contact available.

Overall response rate (ORR) is the percentage of participants on a treatment line who achieve real-world complete response (rwCR) or real-world partial response (rwPR) as best response per treatment line. rwCR: complete resolution of disease; rwPR: partial reduction in size of visible disease in some, or all, areas without any increase in visible disease.

ORR is the percentage of participants on a treatment line who achieve confirmed rwCR or rwPR as best response per treatment line. Confirmed responses are responses that persist greater than or equal to (\>=) 4 weeks after initial response. rwCR: complete resolution of disease; rwPR: partial reduction in size of visible disease in some or all areas without any increase in visible disease.

rwDOR is defined as the time from the date of first rwCR or rwPR after treatment initiation to the date of the first noted occurrence of progressive disease or death. rwCR: complete resolution of disease, rwPR: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.

rwDCR is defined as the percentage of participants who have a rwCR, rwPR, or real-world stable disease (rwSD) assessment during the course of a line of therapy, among all participants in that cohort. rwCR: complete resolution of disease, rwPR: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease, rwSD: no change in overall size of visible disease, or mixed response (some lesions increased, some lesions decreased).

OS is defined as the time from the date of advanced disease diagnosis until the date of death. Participants for whom a date of death has not been identified, will be censored at the date of last contact available.

rwTTD is defined as time from treatment initiation to treatment discontinuation for any reason. Treatment discontinuation is defined as the date of the last drug administered during the same treatment line of therapy or death, whichever occurs earlier. Participants are considered to discontinue treatment if they have advanced to a new line of therapy since the last drug administration, have a recorded date of death, or have no visit activity more than 120 days after the last drug administration.

Takeda

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Adenomatous Polyposis Coli

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Polyps

Adenomatous Polyps

Intestinal Polyposis

Familial Adenomatous Polyposis

MYH-associated Polyposis

Attenuated Familial Adenomatous Polyposis

Cola

Chart review study to evaluate the outcomes of subjects with Attenuated Familial Adenomatous Polyposis (AFAP) who have not undergone surgical resection of the colon.

Chart review study to evaluate the outcomes of subjects with Deleterious Familial Adenomatous Polyposis (FAP) who have not undergone surgical resection of the colon.

Database queried for the presence of cases meeting criteria (attenuated FAP, classical AFP \[i.e. identifiable APC mutation\], and/or a compatible family history or personal adenoma burden of \> 50 adenomas).

The data related to the patients with attenuated FAP and classical AFP who underwent endoscopic surveillance or surgery collected through chart review and all data is retrospective as of February 15, 2016.

Patrick Lynch, MD, JD

The primary objective of this chart review study is to evaluate the outcomes of subjects with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP) who have not undergone surgical resection of the colon.

A secondary objective of this study is to compare 1) the colonoscopic and pathology histories including history of ampullary adenoma in the duodenum over family generations, 2) the use of chemopreventive medications, and 3) clinical features of subjects who pursued prophylactic surgical resection of the colon with those that have elected to continue routine colonoscopic surveillance in an effort to better characterize factors (e.g. polyp burden, ampullary adenoma and level of dysplasia, etc) which may influence management decisions.

The UTMDACC family history database will be queried for the presence of cases meeting the above criteria (attenuated Familial Adenomatous Polyposis (FAP), classical AFP \[i.e. identifiable APC mutation\], and/or a compatible family history or personal adenoma burden of \> 50 adenomas).

The data related to the patients with attenuated FAP and classical AFP who underwent endoscopic surveillance or surgery will be collected through chart review and all data is retrospective as of February 15, 2016.

The University of Texas MD Anderson Cancer Center (UTMDACC) medical record number for these cases will be used to identify the patient in ClinicStation: 1) records of endoscopy procedures, 2) operative reports, and 3) associated clinic notes will be reviewed for: a) whether the above evaluation criteria have been met, b) age, c) gender, d) age at initial colonoscopy, e) total number of colonoscopies, f) number of adenomas identified, g) cancer diagnoses, h) chemopreventive medications, i) type of surgery, j) number of hospitalizations, k) length of hospital stay, l) identification of an underlying APC mutation, and ll) family history information. The UT MDACC family history database will also be reviewed for updated family history information including ampullary adenomas and outcomes of genetic testing for identified cases.

Non-Surgical Management of Attenuated and Deleterious (Classical) Familial Adenomatous Polyposis: A Long-term Surveillance Program

For comparisons between groups, the Mann-Whitney test used.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Role of the EKG in Anticancer Drug Development	NCT01462383	Advanced Cancer		-	M.D. Anderson Cancer Center
Overall and Disease Specific Survival in Patients With Confirmed MEN1 With or Without PNET (Pancreatic Neuroendocrine Tumors)	NCT03043508	Genetic Mutatio... MEN1	Chart Review Questionnaire	18 Years -	M.D. Anderson Cancer Center
Azilect + Antidepressant Chart Review	NCT00955604	Serotonin Syndr...	Group R+AD Rasa... Group R Rasagil... Group AD Anti-P...	-	Teva Branded Pharmaceutical Products R&D, Inc.
A Chart Review Study of Adults With Advanced NSCLC	NCT05207423	Non-small Cell ...		18 Years -	Takeda
Azilect + Antidepressant Chart Review	NCT00955604	Serotonin Syndr...	Group R+AD Rasa... Group R Rasagil... Group AD Anti-P...	-	Teva Branded Pharmaceutical Products R&D, Inc.
Non-Surgical Management of Attenuated and Deleterious (Classical) Familial Adenomatous Polyposis: A Long-term Surveillance Program	NCT02747862	Attenuated Fami... Deleterious Fam...	Chart Review	-	M.D. Anderson Cancer Center
Azilect + Antidepressant Chart Review	NCT00955604	Serotonin Syndr...	Group R+AD Rasa... Group R Rasagil... Group AD Anti-P...	-	Teva Branded Pharmaceutical Products R&D, Inc.
Azilect + Antidepressant Chart Review	NCT00955604	Serotonin Syndr...	Group R+AD Rasa... Group R Rasagil... Group AD Anti-P...	-	Teva Branded Pharmaceutical Products R&D, Inc.
Overall and Disease Specific Survival in Patients With Confirmed MEN1 With or Without PNET (Pancreatic Neuroendocrine Tumors)	NCT03043508	Genetic Mutatio... MEN1	Chart Review Questionnaire	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for chart review

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